kvlevis oqmiL

kvlevis oqmis versia 3: 07/02/05 EudraCT nomeri 2004-002955-14

kvlevis oqmiL

saerTaSorisoL GEORGIA

didi, randomizirebuli, placebo-kontrolirebadi kvleva, romelic gamoavlens mwvave travmuli sisxldenebisa an misi SesaZlo arsebobis dros antifibrinolizuri mkurnalobis gavlenas transfuziis moTxovnilebasa da sikvdilobis maCvenebelze

CRASH2 kvlevis oqmi – saerTaSoriso

sarCevi gverdi

1. monacemebi o Sesavali; meqanizmi; arsebuli codna 1 o hipoTeza; kvlevis saWiroeba 2 dozis SerCeva 2

2. kvlevis dizaini Sejameba 4 kvlevisTvis saWiro pacientTa ricxvi 4 o SemTxvevaTa gansazRvruli sixSire; mkurnalobis mosalodneli efeqturobis moculoba; nimuSis sidide;

sxva gamosavalze zemoqmedeba 4

SerCeviToba 5 o CarTvis kriteriumebi; arCarTvis kriteriumebi; SerCeviTobis

specialuri kriteriumebi 5 o SerCeviTobis cxrili 6 Tanxmoba 6 randomizacia 6 mkurnaloba 7 seriozuli SesaZlo moulodneli gverdiTi movlena 7 mosalodneli Tanmxlebi efeqtebi 7 gaSifvra 8 gamosavlis maCvenebeli 8 o pirveladi gamosavlis maCvenebeli; meoradi gamosavlis maCvenebeli; monacemTa Segroveba; kvlevis dasasruli 8 analizi 8

3. organizacia monacemTa monitorirebis komiteti 9 o standartuli operaciuli procedurebi 9 dRis wesrigis komisia 10 o standartuli operaciuli procedurebi 10 TanamkvlevarTa valdebulebebi 10 koordinaciuli centris movaleobebi 11 publikacia 11 kompensacia 11 finansuri mxardaWera 11

4. gamoyenebuli literatura 12

danarTebi 1 informacia pacientebis, maTi naTesavebisa da axloblebisTvis 13 2 pacientis hospitalizaciis forma 15 3 gamosavlis forma 17 4 kvlevis oqmis Sejameba 18

CRASH2 kvlevis oqmi - saerTaSoriso

kvlevis oqmis versia 3:07 Tebervali 2005 1 / 18 EudraCT nomeri 2004-002955-14

didi, randomizirebuli, placebo kontrolirebadi kvleva, romelic

gamoavlens mwvave travmuli sisxldenebisa an misi SesaZlo arsebobis dros

antifibrinolizuri mkurnalobis gavlenas transfuziis moTxovnilebasa da

sikvdilobis maCvenebelze

1 . monacemebi

Sesavali: sikvdilobis maCveneblis mixedviT travmul dazianebebs 5 – 45

wlis asakobriv jgufSi meore adgili uWiravs adamianis

imunodeficituri sindromiT gamowveuli sikvdilobis Semdgom.

msoflioSi yovelwliurad daaxloebiT sami milioni adamiani kvdeba

travmis Sedegad, maTgan bevri – hospitalizaciis Semdgom.1 sikvdilobis

ZiriTadi mizezi hospitalizirebul pacientebSi SemTxvevaTa naxevarSi

mwvave sisxldenaa.2 sikvdilobis ufro xSiri mizezi – centraluri

nervuli sistemisa da multiorganuli dazianebebia, romelTa SesaZlo

garTulebebsac mwvave sisxldena warmoadgens.3

meqanizmi: travmuli an qirurgiuli genezis mwvave sisxlZarRvovani

dazianebisas cirkulatoruli sistemis mTlianobis SenarCunebas

hemostazuri sistema uzrunvelyofs.4 hemostazi Tanabrad pasuxobs

sisxlZarRvis rogorc operaciul, aseve travmul dazianebas, ris

Sedegadac koagulaciuri sistemis sapasuxo reaqcia – masiuri sisxldena

iwyeba. nebismier SemTxvevaSi qirurgiisa da travmis sapasuxo reaqciaTaA

nawili sisxlis koltis daSlis stimulirebaa (fibrinolizi), romelic

rig SemTxvevaSi SeiZleba gaxdes paTologiuri (hiperfibrinolizi).4 antifibrinolizuri saSualebebi mowodebulia sisxldenis SeCerebis mizniT

pacientebSi rogorc normaluri, aseve momatebuli fibrinolizuri pasuxiT

qirurgiul Carevaze. amasTan, aRsaniSnavia, rom operaciis Semdgomi

garTulebebisa da venuri Tromoemboliis riski ar matulobs.5 arsebuli codna: sistemuri antifibrinolizuri saSualebebi farTod

gamoiyeneba qirurgiaSi fibrinolizis Tavidan acilebisa da Sesabamisad,

Tanmxlebi qirurgiuli sisxldenebis Semcirebis mizniT. gegmiur

qirurgiul pacientebSi antifibrinolizuri saSualebebiT (ZiriTadad

aprotonini an traneqsamis mJava) randomizirebuli kvlevebis uaxlesi

sistemuri mimoxilviT 6 identificirda 89 kvleva, romelSic CarTul iqna

8,580 pacienti (74 kvleva kardio, 8 – orTopediul, 4 – RviZlis da 3 –

sisxlZarRvTa qirurgiaSi). Mmkurnalobis Sedegebma aCvena, rom

pacientebSi transfuziis saWiroeba Semcirda 1/3 –iT, transfuziis

moculoba Semcirda erTi erTeuliT, reoperaciaTa ricxvi ganmeorebiTi

sisxldenebis gamo ganaxevrda. yvela am sxvaobam Seadgina statistikurad



mniSvnelovani jgufi. antifibrinolitikebiT namkurnalev pacientebSi

agreTve dafiqsirda statistikurad aramniSvnelovani sikvdilobis

maCveneblis Semcirebac (RR=0.85: 95% CI 0.63 to 1.14). hipoTeza: Bradganac travmis Semdgomi koagulaciuri darRvevebi

postqirurgiuli darRvevebis msavsia, anifibrinolizuri saSualebebis

gamoyenebiT SesaZloa sisxlis danakargis, transfuziis saWiroebisa da

sikvdilobis maCveneblis Semcireba travmuli dazianebebis drosac.

Tumca, Catarebulia mxolod erTi patara randomizirebuli sakontrolo

kvleva (70 randomizirebuli pacienti, medikamenti/placebo : 0/3

sikvdiloba) antifibrinolizuri saSualebebis gamoyenebaze mZime

travmebis dros.7 ris Sedegad miRebulia arasakmarisi faqtebi

mkurnalobis klinikurad mniSvnelovani efeqturobis Sesafaseblad.

sistemuri antifibrinolizuri saSualebebi warmatebiT gamoiyeneba

Tvalis travmebis menejmentSi, sadac ganmeorebiTi hemoragiebis

sixSireTa Semcirebis faqtebia aRwerili.8 kvlevis saWiroeba: travmuli sisxldenebis SeCerebis martivma da Zalzed

praqtikulma mkurnalobam yovelwliurad SeiZleba Tavidan agvacilos

aTasobiT naadrevi travmuli sikvdili da meores mxriv, Seamciros

transfuziiT gamowveuli inficirebis riski. sisxli saxifaTo da Zviri

produqtia da transfuziaasocirebuli infeqciebi kvlav rCeba didi

polemikis sagani. gansakuTrebiT sayuradReboa qveynebi, sadac sisxlis

transfuziis usafrTxoeba ar aris sarwmuno. ugandaSi Catarebulma

bolo gamokvlevam gamoaSkarava, rom aiv-inficirebul mosaxleTa

daaxloebiT 2 % asocirebulia sisxlis transfuziasTan, Tumca

procentuli maCvenebeli sxva monacemebiT ufro maRalia.9,10 msoflio

jandacvis organizaciis 191 wevri qveynebis mxolod 43% amowmebs sisxls

aiv- da C da B virusebze. yovelwliurad sisxlis daudevari gadasxma da

ineqciebi iwvevs 8-16 mln B hepatitis virusiT, 2.3 – 4.7 mln C hepatitis virusiTa d 80.000 – 160.000 aiv-iT dasnebovnebis SemTxvevebs.11 swored amitom, travmis Sedegad hospitalizirebuli pacientebis farTo jgufSi,

romelTac aReniSnebaT sisxldenis maRali riski, romelic mkveTrad

gaauaresebs maTi gadarCenis Sansebs, saWiroa Catardes didi

randomizirebuli kvleva iseTi martivi, iafi da metad praqtikuli

antifibinolizuri saSualebis gamoyenebiT, rogoricaa traneqsamis mJava

(aprotonini sagrZnoblad Zviria, Zroxis produqtia da Sesabamisad,

alergiul reaqciaTa riski maRalia; arsebobs mosazreba, rom daavadebis

gadamtania).

dozis SerCevaN qirurgiaSi antifibrinolizuri saSualebebiT randomizirebuli

sakontrolo kvlevebis sistemurma mimoxilvam aCvena, rom traneqsamis

mJavis dozireba variabeluria.6 datvirTvis doza meryeobs 2.5 mg/kg-dan

100 mg/kg-mde da SemanarCunebeli doza – 0.25 mg/kg/sT-dan 4 mg/kg/sT-mde

pirveli 12 saaTis intervalSi. xvadasxva dozebiT traneqsamis mJavis

moqmedebis Sefasebis kvlevam sisxldenebsa da transfuziis

moTxovnilebebze, mniSvnelovani sxvaoba maRal da dabal dozebs Soris

ar aCvena.



kardioqirurgiaSi Catarebulma kvlevam aCvena, rom traneqsamis mJavis

sawyisma dozam 10 mg/kg-is moculobiT, romelic grZeldeboda 1mg/kg/sT

infuziiT, plazmaSi Seadgina sakmarisi koncetracia fibrinolizis

inhibirebisaTvis in vitro gamokvlevaSi.12 traneqsamis mJavis doza-

damokidebuli efeqti Seswavlili iqna Horrow at al-isDAmier (1995),

romelmac daaskvna, rom traneqsamis 10 mg/kg Semdgomi 1mg/kg/sT infuzia

eqstrakorporaluri sisxlismimoqcevis Semdgom amcirebs sisxldenas da

ufro maRali dozebi hemostazze damatebiT sargebels ar axdens. 13

gadaudebel situaciaSi fiqsirebuli dozis Seyvana metad praqtikulia,

radganac pacientis wonis gansazRvra am SemTxvevaSi SeuZlebelia.

amasTan, fibrinolizis inhibirebisa da hemostazis Sesabamisi

pasuxisaTvis saWiro zemoT aRniSnuli doza efeqturia didi wonis

pacientebSi (>100kg) da usafrTxoa mcire wonis pacientebSi (<50kg) da

Semdgomi gansazRvruli doza kg masaze gaangariSebiT sxva kvlevebSi

gverdiTi movlenebis gareSea dafiqsirebuli. traneqsamis mJavis

dagegmili xangrZlivobiTDgadasxma sisxldenebis saSiSroebis dros,

saSualebas iZleva miRebuli iqnas misi moqmedebis swrafi efeqti da

xels uSlis mwvave pasuxis fazis Camoyalibebas, romelic xSirad

aRiniSneba qirurgiuli Carevisa da travmis dros.

A



2 . kvlevis dizaini Sejameba

A

CRASH2 didi, pragmatuli, randomizirebuli, placebokontrolirebadi

klevaa antifibrinolizuri saSualebis - traneqsamis mJavis adreuli

infuziiT da misi efeqtis SefasebiT sikvdilobis maCvenebelze,

sisxlZarRvovan movlenebsa da transfuziis saWiroebaze. travmidan

pirveli 8 saaTis ganmavlobaSi mozrdili pacienti mniSvnelovani

hemoragiiT an misi ganviTarebis riskiT SesaZlebelia CarTuli iqnas

kvlevaSi im SemTxvevaSi, Tu eqimi Tvlis, rom ar aris

antifibrinolizuri saSualebebis aucileblobis an ukuCvenebis

viTareba. medikamentis an placebos danomrili kolofebi xelmisawvdomi

iqneba kvlevaSi monawile yvela gadaudebel ganyofilebaSi.

randomizacia moxdeba 24 saaTiani ufaso satelefono randomizaciis

servisis saSualebiT. zaris xangrZlivoba gastans 1 an 2 wuTs da

randomizaciis servisis dasasruls gairkveva kvlevaSi gamosayenebeli

kolofis nomeri. im samedicino dawesebulebebSi, sadac satelefono

servisi ar aris xelmisawvdomi, pacientTa randomizacia moxdeba

samkurnalo kolofebis nomrebis zrdadobis mixedviT. damatebiTi

gamokvlevebi ar aris saWiro. ivseba mxolod mokle forma erTi Tvis

Semdgom an pacientis gaweris an sikvdilis SemTxvevaSi (romelic

pirveli moxdeba).

kvlevisTvis saWiro pacientTa ricxvi

kvlevisTvis saWiro pacientTa ricxvs gansazRvravs 2 mTavari faqtori.

es aris SemTxvevaTa gansazRvruli sixSire da mkurnalobis

efeqturobis moculoba. SemTxvevaTa gansazRvruli sixSire: MRC (samedicino kvlevaTa

sakonsulo) CRASH kvlevaSi - (kortikosteroidebi qala tvinis travmebis

dros), sikvdilobis mTlianma riskma Seadgina 20%.14 MRC CRASH kvleva

travma pacientebSi msoflioSi udidesi saerTSoriso randomizirebuli

sakontrolo kvleva iyo da damajerebeli iqneba, Tu CRASH2 kvlevis

sikvdilobis riskis maCvenebeli iqneba analogiuri. mkurnalobis mosalodneli efeqturobis moculoba: Bradganac iseTi

martivi da praqtikuli saSualebebis gamoyenebiT, rogoricaa traneqsamis

mJava, miRebuli gadarCenis 2% upiratesoba Rirebul sargebels

warmoadgens, mimdinare kvleva miznad isaxavs gamoavlinos anologiuri

maCveneblis sargebeli. nimuSis sidide: Tu sikvdilianobis Sefardebis realuri maCvenebelia

20% Sefardebuli 18%, daaxloebiT 85% Sansia imisa, rom kvleviT,

romelmac unda moicvas 20000 pacinti, miiRweva 2P<0.01 (da 95% Sansia

imisa, rom miiRweva 2P<0.05). Tumca, Tu kvlevaSi CasarTav pacientTa

ricxvi ganaxevrdeba, 50% Sansia imisa, rom ver iqnas miRweuli 2P<0.01



( da 28% Sansi imisa, rom ver iqnas miRweuli 2P<0.05), romelic, ra Tqma

unda, arcTu saxarbieloa.

sxva gamosavalze zemoqmedeba: randomizirebul pacientTa am

raodenobis pirobebSi, transfuziis saWiroebisa an transfuziis

moculobis saSualo raodenoba, iseve, rogorc nebismieri sxva

arafataluri sisxlZarRvovani efeqti (hemoragiuli an okluziuri)

zedmiwevniT zustad iqneba gansazRvruli.

SerCeviTobaY

o KkvlevaSi erTveba mozrdili pacientebi travmuli dazianebiT,

travmidan pirveli 8 saaTis intervalSi, romelTac aReniSnebaT mwave

sisxldena an misi ganviTarebis riski; gamoklebiT im pacientebisa,

romelTaTvisac antifibrinolizuri saSualebebi Zalzed aucilebelia

an Zalzed ukunaCvenebia.

CarTvis kriteriumebi: kvlevaSi erTveba yvela pacienti travmidan 8

saaTis intervalSi arsebuli sisxldeniT (sist.wneva <90 mmHg da/an

gulis SekumSvaTa sixSire >110/wT), an riskiT sisxldenaze, rodesac maTi

asaki 16 welze metia. KkvlevaSi CarTva SesaZlebelia travmidan pirveli

8 saaTis Semgomac, Tumca naadrevad dawyebuli mkurnaloba

pacientisTvis metad sasargebloa.

arCarTvis kriterumebi: pacientis kvlevaSi CarTvis ZiriTad

gadawyvetilebas iRebs mkurnali eqimi. Tu eqimi darwmunebulia, rom

pacients aucileblad esaWiroeba antifibrinolizuri Terapia, is

kvlevaSi ar irTveba. Aaseve, Tu mkurnali eqimi Tvlis, rom

antifibrinolizuri Terapia garkveul SemTxvevaSi ukunaCvenebia (mag.

diseminirebuli sisxlZarRvSida Sededebis sindromis klinikuri

niSnebis arsebobisas), pacienti kvlevaSi ar erTveba. im SemTxvevaSi,

rodesac mkurnali eqimi orWofobs gamoiyenos Tu ara

antifibrinolizuri saSualeba, pacienti erTveba kvlevaSi. sxva

specifiuri arCarTvis kriteriumebi ar arsebobs. A

am tipis kvlevaSi CarTul pacientTa mravalferovnebas Sedegebis

gamoaSkaravebisTvis mniSvnelovani roli eniWeba. Tu kvlevaSi CairTveba

pacientTa farTo speqtri, iseTi didi kvlevisaTvis, rogoric es aris,

SesaZlebeli gaxdeba pacientTa im tipis gamovlena, romlebmac

mkurnalobidan meti sargebeli miiRes (Tu saerTod miiReben).

SerCeviTobis specialuri kriteriumebi: Nar arsebobs. Mmwvave Zlieri

sisxldenis arsebobis pirobebSi rutinulad gamoricxva pacientebisa,

romelTac anamnezSi Tromboemboliuri daavadeba aReniSnebaT, ar aris

saWiro, Tu pasuxismgebeli eqimi ar miiCnevs rom es aSkara ukuCvenebaa.

mokle informacia im pacientebisa, romlebic SeirCevian magram ar

CairTvebian kvlevaSi, Caiwereba pacientis skriningis formaSi TiToeul

Tanamonawile centrSi.



TanxmobaN

pacientebs mniSvnelovani travmuli dazianebebiT SesaZloa hqondeT

Secvlili cnobiereba da saTanadod ver SeZlon informirebuli

Tanxmobis mocema. aseT gadaudebel situaciaSi mkurnalobis dawyebis

gadadeba medicinaSi aragamarTlebulia. Tanxmobis miReba SesaZlebelia

an personaluri an profesionaluri legaluri warmomadgenlisagan,

sadac rogor aris marTebuli. agreTve yovelTvis gasaTvaliswinebelia

eTikuri komitetis moTxovnebic. PpacientisTvis gankuTvnili kvlevis

sainformacio broSura (danarTi 1) moyveba medikamentis yvela pakets

damatebiT lokaluri warmomadgenlis Tanxmobis formasTan (mxolod

evrosabWos wevri qveynebisaTvis - danarTi 1a).

randomizaciaNON

pacientebi, romlebic SeirCevian kvlevaSi CarTvisTvis, unda

randomizirdnen da mkurnaloba daewyoT SeZlebisdagvarad swrafad.

randomizacia tardeba 24 saaTiani ufaso satelefono servisiT, romelic

grZeldeba daaxloebiT 2 wuTi. Ppacientis hospitalizaciis forma

(danarTi 2) moicavs SekiTxvebs, romelsac svams operatori samkurnalo

paketis SerCevamde. Semdgom kvlevis kompiuteri brmad gansazRvravs

samkurnalo paketis nomers, romelic Seesabameba gadaudebeli medicinis

cxrili 1: SerCeviToba

konkretul pacientSi eqimi “meryeobs”

antifibrinolizuri saSualebebis

saWiroebaSi

traneqsamis mJava placebo

eqimi “myarad darwmunebulia”, rom

antifibrinolizuri saSualebebi

aucilebelia.

araarCeviTia.

mieciT antifibrinolizuri

saSualebebi.

ar eqvemdebareba randomizacias



ukunaCvenebia.

araarCeviTia.

ar misceT antifibrinolizuri

saSualebebi.


potenciurad arCeviTipacientebi travmidan pirveli 8 sT-is

ganmavlobaSi, mniSvnelovani sisxldeniT

(sistoluri arteriuli wneva < 90 mmHg da/an gulis SekumSvaTa sixSire > 110 wT) an misi

ganviTarebis riskiT, romelTa asaki > 15

darekeT randomizaciisTvis

an randomizirdes furcliT

konkretul pacientSi eqimi “meryeobs”

antifibrinolizuri saSualebebis

saWiroebaSi

traneqsamis mJava placebotraneqsamis mJava placebo



aucilebelia.

araarCeviTia.

mieciT antifibrinolizuri

saSualebebi.




ukunaCvenebia.

araarCeviTia.

ar misceT antifibrinolizuri

saSualebebi.


potenciurad arCeviTipacientebi travmidan pirveli 8 sT-is

ganmavlobaSi, mniSvnelovani sisxldeniT

(sistoluri arteriuli wneva < 90 mmHg da/an gulis SekumSvaTa sixSire > 110 wT) an misi

ganviTarebis riskiT, romelTa asaki > 15

darekeT randomizaciisTvis

an randomizirdes furcliT



ganyofilebaSi Senaxul erT-erT CRASH2 samkurnalo pakets. im

SemTxvevaSi rodesac telefoniT randomizacia ar aris xalmisawvdomi,

gamoiyeneba adgilobrivi paketis sistema. Aam tipis saavadmyofoebSi

sabaziso informaciis Segroveba xdeba kvlevis hospitalizaciis formis

saSualebiT da yvela Semdgomi samkurnalo paketis SerCeva 8 paketiani

samkurnalo yuTidan nomrebis Tanmimdevruli zrdadobis mixedviT xdeba.

mas Semdeg rac pacienti randomizirdeba, Cveni survilia saavadmyofoSi

misi gamosavlis codna, im SemTxvevaSic ki Tu sakvlevi medikamentiT

mkurnaloba Sewydeba an saerTod ar Catardeba.

mkurnaloba

TiToeul CRASH2 samkurnalo paketSi devs:

• traneqsamis mJavis an placebos 4 x 500 mg ampulebi

• 0.9% NaCl-is 1 X 100 ml paketi (datvirTvis dozisTvis)

• misakravebi (sainfuzio xsnarebisa da SeniSvnebisTvis)

• pacientis sainformacio broSura da Tanxmobis forma

• pacientis hospitalizaciisa da gamosavlis formebi

mkurnaloba MK

ampulebi AMPOULE

doza (traneqsamis

mJava an placebo)DODOA

infuziis sixSire da xangrZlivoba

datvirTvis

doza 2 1 grami

100 mlL10 wuTis

ganmavlobaSi

SemanarCunebeli

doza 2 1 grami

120 mg/sT [60 ml/sT] 8

saaTis ganmavlobaSi

seriozuli SesaZlo moulodneli gverdiTi movlenebiU

seriozuli SesaZlo moulodneli gverdiTi movlenebis arsebobis

SemTxvevaSi, romelic savaraudod sakvlevi preparatiT aris gamowveuli,

aucilebelia mis Sesaxeb satelefono kavSiriT vacnoboT 24 saaTian

randomizaciis serviss, romelic informacias londonis koordinaciul

centrs miawvdis, ris Semdegac es ukanaskneli dagikavSirdebaT 24 saaTis

ganmavlobaSi raTa Seivsos seriozuli SesaZlo moulodneli gverdiTi

movlenebis werilobiTi forma.

mosalodneli Tanmxlebi efeqtebiP

zogadad im sisxlZarRvovani cvlilebebis aRwera, rogoricaa filtvis

arteriis embolizacia, Rrma venebis Tombozi, iSemiuri insulti,

miokardiumis infarqti, gastrointenstinuri sisxldena da

multiorganuli dazianeba ar aris saWiro, radganac antifibrinolizuri

Terapiis fonze maTi ganviTarebis sixSiris mateba mosalodnelia. Aaseve,

sxva samedicino movlenebis aRwera, romlebsac SesaZloa adgili

hqondeT pacientebSi mZime travmuli dazianebiT, telefoniT ar aris

aucilebeli. TumcaRa, yvela es movlena rutinulad monitorirdeba

yvela pacientSi da aRiwereba gamosavlis formaSi (danarTi 3).



gaSifvra

zogadad, daniSnuli mkurnalobis gaSifvra saWiroebas ar warmoadgens.

Tu randomizaciis Semdgom arsebobs antifibrinolizuri Terapiis

ukuCveneba (mag. Trombozis klinikur niSnebi), sakvlevi preparatiT

mkurnaloba unda SeCerdes. GgaSifvra xdeba mxolod im erTeul

SemTxvevaSi, rodesac eqimi darwmunebulia, rom klinikuri menejmenti

mniSvnelovnad damokidebulia imis codnaze pacientma

antifibrinolitiki miiRo Tu placebo. Aam erTeul SemTvevaSi, rodesac

saswrafo gaSifvra aucilebeli xdeba randomizaciis serviss

satelefono kavSiriT unda ecnobos gaSifvris pasuxismgebeli eqimis

saxeli da samkurnalo paketis nomeri, ris Semdgomac eqims ecnobeba

pacientma antifibrinolitiki miiRo Tu placebo.

gamosavlis maCvenebeliME

Ppirveladi gamosavlis maCvenebeli:

o travmidan 4 kviris ganmavlobaSi sikvdili saavadmyofoSi (sikvdilis mizezi unda

aRiweros, raTa ganisazRvros iyo is gamowveli sisxldeniT Tu sisxlZarRvovani

okluziiT).

meoradi gamosavlis maCveneblebia: sisxlisa da misi produqtebis

transfuziis moTxovnileba, gadasxmuli sisxlisa da misi produqtebis

erTeulebis raodenoba, qirurgiuli Careva, Trombo-emboluri epizodebis

sixSire (insulti, miokardiumis infarqti, filtvis arteriis embolia,

Rrma venebis Trombozis klinikuri niSnebi). monacemTa Segroveba: intrahospitaluri sikdilianoba, transfuziis

moTxovnileba, garTulebebi da mokle droSi gamojanmrTeleba

fiqsirdeba gamosavlis formaSi (danarTi3), romlis srulad Sefaseba

SesaZlebelia avadmyofobis istoriidan - damatebiTi testi ar aris

saWiro. Ggamosavlis forma ivseba sikvdilis, saavadmyofodan gaweris an

travmidan 4 kviris Tavze, romelic moxdeba pirvelad. kvlevis dasasruli: sikvdili, saavadmyofodan gawera an

randomizaciidan 4 kvira, romelic moxdeba pirvelad.

analizi

Sedareba daeyrdnoba im pirveladi gamosavlis maCvenebels, romelic

gamovlindeba asocirebuli antifibrinolizuri mkurnalobis Sedegebis

SedarebiT asocirebul placebosTan e.w. ,,swrafva mkurnalobisaken”

safuZvelze dayrdnobiT. analizis gamotana daeyrdnoba dros travmis

miRebidan mkurnalobis dawyebamde (naklebi 1 saaTze, 1 dan 3 saaTamde, 3

sT-ze meti), sisxldenis simwvaves, romelic Sefasdeba kapilaruli

avsebis droiT (0-2, 3-4, > 5 wm) da sistoluri art. wnevas (<75, 76-89, >89

mmHg). Sedareba aseve daeyrdnoba sisxlisa da misi produqtebis

transfuziis risks, operaciis saWiroebasa da Trombo-embolur

garTulebebs.



3 . organizacia

monacemTa monitorirebis komiteti profesori rori kolinsi, Tavjdomare

profesori adrian granti

profesori jon a. maiburgi

standartuli operaciuli procedurebi: monacemTa monitorirebisa da

eTikuri komisia (DMEC) randomizaciis msvlelobisas pasuxismgebelia

gadawyvitos warudginos Tu ara dRis wesrigis komisias gaSifruli

Sedegebi (an garkveuli qvejgufis gaSifruli Sedegebi). DMEC SeTanxmebis Tanaxmad amtkicebs, rom amas gaakeTebs mxolod im

SemTxvevaSi, rodesac dakmayofilebuli iqneba 2 piroba: (1) Sedegebi

mkafiod daamtkicebs rom mkurnaloba an aSkarad sazianoa an aSkarad

sasikeTo yvela an garkveuli kategoriis pacientebisaTvis saboloo

gamosavalTan mimarTebaSi. (2) Sedegebi, Tu gamoaSkaravda, savaraudod

TandaTanobiT Secvlian im eqimebis SemuSavebul struqturas, romlebsac

ukve aqvT informacia nebismieri sxva kvlevis arsebuli Sedegebis

Sesaxeb. zusti kriteriumebi ,,mtkiceba yvela mizez gareSe”-sTvis ar aris

da verc iqneba srulad maTematikuri SeCerebis wesiT specifirebuli,

magram am tipis kanonebis mkveTri zegavlenis qveS aris. DMEC wevrebma MRC leikemiis komitetisadmi gamoxates simpaTia SeCerebis kanonis

mimarT, romelic wardgenil iqna 1976 wlis moxsnebis I nawilSi, ris

Sedegadac zogadad, saboloo Sedegebis Sualeduri analizi, naadrevi

aRmoCenis dadasturebisTvis, saWiroa moicavdes sul mcire 3

standartuli Secdomis mkurnalobis Sedarebas sakontrolo jgufTan.

qvejgufis Sualeduri analizi, ra Tqma unda metad mkafio unda iyos,

raTa dadasturdes aRmoCena. am kanons is upiratesoba aqvs, rom

Sualeduri analizis zusti ricxvi da dro ar saWiroebs winaswar

gansazRvras. SejamebisTvis, SeCerebis kanoni (romelic warmatebiT iqna

miRebuli sxva kvlevebSi da moicva MRC saerTaSoriso insultis kvleva,

romelmac CairTo 19436 pacienti mwvave insultiT) saWiroebs mkafio

Sedarebebs, raTa daamtkicos naadrevi aRmoCena da moicavs maTematikuri

SeCerebis kanonisa da samecniero msjelobis Sesaferis

urTierTSeTanxmebas.



dRis wesrigis komisia profesori ian franklini (Tajdomare), glazgosa da Sotlandiis

sisxlis gadasxmis universiteti

q-ni brijit Caudri, RoadPeace profesori tim koutsi, laisteris universiteti

eqimi Carlz dikini, sauzamptonis zogadi hospitali

eqimi stiv gudakri, Sefildis universiteti

eqimi beverli j hanti, Guy's & St Thomas' hospitali NHS Trust eqimi devid medingsi, msoflios jandacvis organizacia

profesori ser riCard peto, oqsfordis univesiteti

profesori ian robertsi, londonis higienisa da tropikuli

medicinis skola

profesori piter sanderkoki, edinburgis universiteti sakontrolo komiteti Sedgeba gamocdili da cnobili travma- da

hematologi eqspertebis, klinikuri mkvlevarebisa da rigi

warmomadgenlebis mier. maTi pirispir Sexvedra isazRvreba saWiroebis

mixediT drois garkveul intervalSi, maram araumcires 1 wlis

monakveTSi. ZiriTadi kontaqti xdeba el-fostisa da fostis saSualebiT.

standartuli operaciuli procedurebi: dRis wesrigis komisia kvlevis

oqmis Tanaxmad kvlevis mimdinareobis intervalSi pasuxismgebelia: o miiRos ZiriTadi gadawyvetilebebi, mag. garkveuli mizezebis gamo

Secvalos kvlevis oqmi

o monitorireba da zedamxedveloba gauwios kvlevis mimdinareobas

o moiZios msgavsi informacia sxva wyaroebidan

o ganixilos monacemTa monitorirebisa da eTikuri komitetis mier

mowodebuli rekomendaciebi

o menejmentis jgufs miawodos rCevebi da informacia kvlevis yvela

aspeqtis Sesaxeb

TanamkvlevarTa valdebulebebi TiToeul Tanamonawile saavadmyofoSi kvlevis koordinatori

adgilobrivi TanamSromelia, romelic valdebulia:

o gaacnos kvlevis yvela detali da saWiro procedurebi eqimebsa da

eqTnebs, romlebic axorcieleben kvlevas da darwmundes maTi codnis

simyareSi (kedlis grafebis, jibis kartebisa da slaidebis daxmarebiT)

o darwmundes, rom pacienti saTanadod SerCeulia kvlevisTvis

o darwmundes, rom pacientis hospitalizaciis forma (arasatelefono

randomizaciis centrebSi) da erTgverdiani gamosavlis forma

Sevsebulia

o darwmundes, rom kvleva tardeba ICH GCP –is Sesabamisad da asrulebs

yvela nacionalur da adgilobriv regularul moTxovnebs

o waradginos arsebuli monacemebi auditisa da verificirebisTvis



koordinaciuli centris movaleobebi o uzrunvelyos kvlevis masalebi da 24 sT-iani randomizaciis (da

gaSifvris) servisi

o kvlevis TanamSromelebs regularulad miawodos informacia kvlevis

mimdinareobaze

o pacientis gawerisas darwmundes monacemTa sisruleSi

o kvlevis Sesaxeb pasuxi gasces nebismier SekiTxvas (mag.

Tanamkvlevarisgan)

o darwmundes monacemTa usafrTxoebasa da xarisxianobaSi

o darwmundes, rom kvleva tardeba ICH GCP –is Sesabamisad publikaciaON CRASH2 -is warmateba mTlianad damokidebuli iqneba Tanamonawile

hospitalebis eqimebisa da eqTnebis TanamSromlobaze. Tanamkvlevarebs

yvela Tanamonawile centridan daeniSneba krediti da personalurad

dasaxeldebian kvlevis Tanaavtorad mTavar publikaciaSi. kvlevis

Sedegebi Tavdapirvelad ecnobeba Tanamkvlevarebs. pacientebs Sedegebi

ecnobebaT mediis, kvlevis veb-gverdisa ([email protected]) da

saTanado organizaciebis saSualebiT.

kompensacia

CRASH2 dafinansebulia londonis higienisa da tropikuli medicinis

skolisa (LSHTM) da msoflio jandacvis organizaciis (WHO) mier da ara traneqsamis mJavis mwarmoeblebis mier. londonis higienisa da

tropikuli medicinis skola, rogorc kvlevis koordinaciuli centri,

kisrulobs sponsoris mier dawesebul pasuxismgeblobas da Sesabamisad,

pasuxismgebelia nebismieri aradaudevari, kvlevaSi monawileobis

Sedegad miyenebuli zianisa.

finansuri mxardaWera londonis higienisa da tropikuli medicinis skola da msoflio

jandacvis organizacia afinansebs mxolod Sexvedrebsa da centralur

organizaciul xarjebs. kvlevis dizaini, menejmenti da dafinanseba

absolutur ukukavSirSia traneqsamis mJavis mwarmoeblebTan, romelic

ar aris axali preparati. Ddidi kvlevebiAam tipis wamlebis gamoyenebiT,

romelSic uamravi hospitali monawileobs, Zalian mniSvnelovania

momavali pacientebis mkurnalobisTvis da Rirebulia im TanamkvlevarTa

Soris, romlebic iTanamSromleben anazRaurebis gareSe (gamonakliss

warmoadgens is mcire adgilobrivi xarjebi, romelic SeiZleba

anazRaurdes).



4 . gamoyenebuli literatura 1. Murray CJL, Lopez AD. janmrTelobis globaluri statistika: SemTxvevaTa reziume,

gavrceleba da sikvdiloba ganxiluli 200 SemTxvevaSi. harvardis saxalxo

janmrTelobis skola, bostoni: harvardis universitetis presa, 1996.

2. Sauaia A, Moore FA, Moore E, Moser K, Brennan R, Read RA, Pons PT. travmis sikvdilobis epidemiologia: xelaxla Sefaseba. J Trauma1995;38:185-193.

3. qala-tvinis travmis fondi. amerikis neiroqirurgTa asocacia. neirotravmisa da

kritikuli marTvis erToblivi seqcia. hipotenzia. J Neurotrauma. 2000;17(6-7):591-5.

4. Lawson JH, Murphy MP. efeqturi hemostazis warmoebis mizanswrafva qirurgiasa da travmaSi. Semin Hematol 2004;41:55-64.

5. Porte RJ, Leebeek FW. farmakologiuri strategiebi transfuziis moTxovnebis

Sesamcireblad qirurgiul pacientebSi. medikamentebi 2002; 62: 2193-211.

6. Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. antifibrinolitikebis gamoyeneba intraoperaciuli

alogenuri sisxlis transfuziis SemcirebisTvis (koxranis mimoxilva). koxranis

biblioTeka, gamocema 1, 2004. Chichester, UK: John Wiley & Sons, Ltd.

7. Coats T, Roberts I, Shakur H. antifibrinolitikebi mwvave travmuli dazianebebis

dros (koxranis mimoxilva). koxranis biblioTeka, gamocema 4, 2004. Chichester, UK: John Wiley & Sons, Ltd.

8. Aylward GW, Dunlop IS, Little BC. travmuli hifemis dros sistemuri

antifibrinolitikebis meta analizi. Tvali 1994;8:440-442.

9. Kiwanuka N, Gray RH, Serwadda D, et al. ineqciasa da transfuziasTan asocirebuli

aiv-1 SemTxvevaTa raodenoba ugandas, rakis dasaxlebaSi. AIDS 2004;18:342-343.

10. Heymann SJ, Brewer TF. tranfuziis problema asocirebuli SeZenil

imunodeficitur sindromTan afrikaSi: raodenobrivi midgoma. Am J Infection Control 1992;20:256-62.

11. Goodnough LT, Shander A, Brecher ME. transfuziis medicina: mzera momavalSi. Lancet 2003; 361: 161-9.

12. Fiechtner BK, Nuttall GA, Johnson ME, Dong Y; Sujirattanawimol N, Oliver WC Jr, Sarpal RS, Oyen LJ, Ereth MH. traneqsamis mJavis koncentracia plazmaSi

kardiopulmonaluri baifasis dros. Anesth Analg. 2001; 92(5): 1131-6

13. Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. traneqsamis mJavis doza-damokidebuli moqmedeba. anesTeziologia 1995;82:383-92.

14. WWW.CRASH.LSHTM.AC.UK



danarTi 1

informacia pacientebis, maTi naTesavebisa da axloblebisTvis

travmis Semdgomi

sisxldenis

saerTaSoriso kvleva

informacia da anketa

pacientebis, maTi

naTesavebisa da

axloblebisTvis

travmis Semdgomi sisxldenis saerTaSoriso

kvlevaSi monawileobis misaRebad damatebiTi

informaciisTvis mogvmarTeT:

(CasviT saavadmyofos sakontaqto detalebi)

kvlevis sakoordinacio centri: travmis Semdgomi sisxldenis saerTaSoriso kvleva,

oTaxi 180

londoni, higienisa da tropikuli medicinis skola

Keppel –is quCa London WC1E 7HT didi britaneTi

Tel +44 20 7299 4684 WWW.CRASH2.LSHTM.AC.UK ISRCTN86750102 Version 3: 07/02/05

Cveni klinika monawileobs saswavlo kvlevaSi,

romlis mizania travmis Semdgomi mwvave

sisxldenebis Semcirebis mizniT axali taqtikis

moZebna.

(1) Tqven CarTuli xarT am kvlevaSi

(2) Cven gTavazobT monawileoba miiRoT kvlevaSi

(3) Cveni survilia _______________ (pacientis

gvari) CarTul iqnas kvlevaSi .

(moxazeT Sesabamisi punqti)

ra unda icodeT kvlevis Sesaxeb:

gTavazobT informacias, romelic moicavs kvlevaSi

monawileobis mizans, risksa da sargebels.

pacientebs mwvave sisxldeniT klinikaSi moxvedrisTanave

utardebaT sisxldenis sawinaaRmdego gadaudebeli

mkurnaloba. saswavlo kvlevis mizania mkurnalobis

saukeTeso modelis SerCeva. am mizniT gTavazobT

mkurnalobas traneqsamis mJaviT, romelic xels uwyobs

sisxlis Sededebas da amcirebs sisxlis danakargsa da

misi gadasxmis saWiroebas. gasaTvaliswinebelia isic, rom

mkurnalobis Sedegad warmoqmnili sisxlis koltebi

SeiZleba warmoiqmnas arasasurvel adgilebSic. Cven imedi

gvaqvs, rom mkurnaloba gacilebiT Sedegiani iqneba,

vidre saziano, Tumca es bolomde jer kidev ar aris

cnobili. gTxovT guldasmiT gaecnoT informacias da

damatebiTi SekiTxvebisTvis mimarToT Tqven mkurnal

eqims.

1) ratom tardeba kvleva?

mwvave sisxldenebi, travmuli dazianebebis

Semdgom, sikvdilis erT-erTi ZiriTadi mizezia.

amitom saWiroa gamoiZebnos mkurnalobis saukeTeso

taqtika sisxlis danakargis Semcirebis mizniT.

1(4)

2) ra aris kvlevis mizani?

traneqsamis mJava xSirad gamoiyeneba sisxldenis

SeCerebis mizniT qirurgiaSi, kerZod ki

kardioqirurgiaSi. es kvleva Seiqmna, raTa

Sefasdes sisxldenis Semcirebis mizniT ramdenad

efeqturia traneqsamis mJava mZime travmebis dros.

traneqsamis mJava ar aris axali medikamenti; is

warmatebiT gamoiyeneba mravali mizeziT

gamowveuli sisxldenebis dros.

3) vin atarebs kvlevas?

eqimi ________________________ am klinikaSi

kvlevis pasuxismgebeli piria. kvleva

koordinirebulia londonis universitetis

doqtorebis mier.

4) kvlevaSi CarTvis ukuCvenebebia:

• pacientis asaki < 16

• travmidan gasuli dro aRemateba 8 saaTs

• rodesac eqimi Tvlis, rom garkveuli mizezebis

gamo, traneqsamis mJavis gamoyeneba ar aris

sasurveli

• rodesac eqimi Tvlis, rom garkveuli mizezebis

gamo, traneqsamis mJavis gamoyeneba aucilebelia

5) rogor tardeba kvleva?

pacients utardeba sisxldenis sawinaaRmdego

gadaudebeli Terapia, romelic moicavs sisxlis

Semcvleli xsnarebis infuzias sisxlis danakargis

Sesavsebad. Semdgomi 8 saaTis ganmavlobaSi pacients

Cautardeba mkurnaloba an aqtiuri traneqsamis

mJaviT an araqtiuri preparatiT, e.w. fiziologiuri

xsnariT. mkurnalobis SerCevas (aqtiuri Tu pasiuri)

awarmoebs kompiuteri osfordSi; pacientis

2(4)



informacia pacientebis, maTi naTesavebisa da axloblebisTvis (gagrZeleba)

mkurnali eqimi ar aris informirebuli Tu romeli

tipis mkurnaloba utardeba pacients. es informacia

konfidencialuria da inaxeba londonis erT-erT

klinikaSi. kvleva ar moicavs damatebiT

gamokvlevebs; Tqveni eqimi pacientis mgdomareobis

amsaxvel mokle informacias gamoagzavnis

londonSi, kvlevis sakoordinacio centrSi. es

informacia konfidencialuria da inaxeba kvlevis

TanamSromlebis mier. 6) ra savaraudo garTulebebia mosalodneli

kvlevis ganmavlobaSi? traneqsamis mJava farTo moxmarebis preparatia.

misi gamoyenebis periodSi mniSvnelovani gverdiTi

efeqtebi ar aris gamovlenili. traneqsamis mJava ar

aris axali preparati.

7) kvlevaSi monawileobis upiratesoba vimedovnebT, rom traneqsamis mJava savaraudod

Seamcirebs sisxlis danakargs. zemo aRniSnuli

kvlevis Sedegad miRebuli codna momavalSi

daexmareba rogorc eqimebs, aseve msgavs

mdgomareobaSi myof pacientebs 8) vis unda mimarToT damatebiTi

SekiTxvebisTvis? damatebiTi SekiTxvebisTvis SeigiZliaT mimarToT

eqimi ______________________________________

sakontaqto tel. ____________________________

3(4)

9) romeli informaciaa konfidencialuri?

informacia pacientisa da misi travmis Sesaxeb

konfidencialuria. es informacia xelmisawvdomia

mxolod kvlevaze momuSave eqimebisTvis,

sakoordinacio centris TanamSromelTa da

aRmasrulebel pirTaTvis, romlebic afaseben

kvlevis mimdinareobis koreqtulobas. samedicino

JurnalebSi gamoqveyndeba mxolod kvlevis

Sedegebi sadac pacientis piradi informacia ar

iqneba aRniSnuli.

10) SesaZloa Tu ara pacientisTvis kvleva

dasruldes vadaze adre?

kvleva iwyeba gadaudebel situaciaSi. Cven

vimedovnebT, rom mogvawodebT informacias Tqveni

pacientis Semdgomi mdgomareobis Sesaxeb; Tu Tqven

ar gaqvT amis survili, gTxovT acnoboT mkurnal

eqims.

11) ra damatebiTi informacia unda icodeT? • kvleva dafinansebulia londonis

universitetisa da msoflio jandacvis

organizaciis mier da ara wamlis (traneqsamis

mJava) mwarmoeblebis mier.

• londonis higienisa da tropikuli medicinis

centri, rogorc kvlevis sakoordinacio centri,

kisrulobs sponsoris mier dawesebul

pasuxismgeblobas da, Sesabamisad,

pasuxismgebelia nebismieri aradaudevari,

kvlevaSi monawileobis Sedegad miyenebuli

zianisa.

4(4)

travmis Semdgomi

sisxldenis saerTaSoriso

kvleva

anketa

gavecani kvlevis Sinaars da moxaruli var

1) miviRo monawileoba

2) Cemi gamojanmrTelebis detalebi gamoyenebul

iqnas kvlevaSi

an, Tu Tqven ar xarT pacienti

3) qvemoT aRniSnulma pacientma miiRos monawileoba

4) pacientis gamojanmrTelebis detalebi

gamoyenebul iqnas kvlevaSi

xelmowera: ___________________________________ TariRi: ______________________________________ pacientis saxeli:______________________________ eqimi: ________________________________________ pirovneba, romelic avsebs formas: ____________________________________________

Tu Tqven ar xarT pacienti, miuTiTeT Tqveni naTesauri

kavSiri: ____________________________________________ ISRCTN86750102 Version 3: 07/02/05



danarTi 2

Ppacientis hospitalizaciis forma

PATIENT ENTRYINTERNATIONAL

ALL QUESTIONS BELOW NEED TO BE ANSWERED BEFORE CALLING THE RANDOMISATION SERVICE

INFORMATION ABOUT YOUR HOSPITAL

1. Country

2. Name of hospital (or your hospital code)

3. Name of caller

INFORMATION ABOUT THE PATIENT

4. Patient sex (please circle) Male Female 5. Patient initials

6. Patient hospital identification number

7. Do you know patient’s date of birth?

a. YES – date of birth YEAR MONTH DAY b. NO – approximate age INFORMATION ABOUT THE INJURY

8. Estimated number of hours since injury hours

9. Type of injury (please circle) 1 Blunt 2 Penetrating 3 Both

FIRST MEASUREMENT IN HOSPITAL OF THE FOLLOWING (IF UNKNOWN GIVE VALUE AT RANDOMISATION)

10. Systolic BP (mmHg) 11. Respiratory rate (per min)

12. Central capillary refill time (sec) 13. Heart rate (per min)

EYE OPENING MOTOR RESPONSE VERBAL RESPONSE 4 Spontaneous 6 Obeys commands 5 Orientated

3 To sound 5 Localising 4 Confused speech

2 To pain 4 Normal flexion 3 Words

1 None 3 Abnormal flexion 2 Sounds

2 Extending 1 None

14. Glasgow Coma Score (max 15)

1 None

Now call Randomisation Service with these answers and write down the treatment pack number given at the end of the phone call

Box Pack Get this pack and follow the instructions on it carefully

Or paper randomise as per instructions in site file



danarTi 2

pacientis hospitalizaciis forma meore gverdi

NOTES:

PLEASE GIVE THIS COMPLETED FORM TO THE PERSON RESPONSIBLE FOR COMPLETING THE OUTCOME FORM AT YOUR HOSPITAL

WHAT TO DO IF A

TREATMENT PACK IS LOST OR DAMAGED

Telephone Randomisation

Service (number in your site file)

o Ask for CRASH2

“LOST OR DAMAGED TREATMENT PACK”

o Give hospital name or

ID code and treatment box/pack number

TO REPORT ADVERSE EVENTS

Telephone Randomisation

Service (number in your site file)

o Ask for CRASH2

“ADVERSE EVENTS” o Give hospital name or


o Give name of the

person who reported the adverse event

………………………………. o Give telephone

number of the person who reported the adverse event

……………………………….

TO UNBLIND

ALLOCATED

TREATMENT

In general there should be no need to unblind the a l located treatment . Unblinding should only be done in those rare cases when management depends importantly upon knowledge of whether the pat ient received tranexamic acid or placebo.

Telephone

Randomisation Service

(number in your site file) o Ask for CRASH2

“UNBLINDING” o Give hospital name or


o A Co-ordinating Centre

team member will be contacted and will help



danarTi 3

Ogamosavlis forma

OUTCOME FORM COMPLETE AT DISCHARGE FROM THE RANDOMISING HOSPITAL,

DEATH IN HOSPITAL OR 28 DAYS AFTER INJURY, WHICHEVER OCCURS FIRST

1. HOSPITAL

2. PATIENT

Patient Initials Hospital ID Number Sex M F

Date of Birth YEAR / MONTH / DAY .

3. OUTCOME 3.2 PATIENT ALIVE

…. Discharged – Date of discharge YEAR / MONTH/ DAY. …. Still in this hospital now (28 days after injury) – Date YEAR / MONTH/ DAY.

3.3 IF ALIVE TICK ONE BOX THAT BEST DESCRIBES THE PATIENT’S CONDITION (at 28 days or prior discharge)

3.1 DEATH IN HOSPITAL

Date of death YEAR / MONTH/ DAY.

Cause of death

…. Bleeding

…. Head injury

…. Myocardial Infarction

…. Stroke

…. Pulmonary Embolism

…. Multi organ failure

…. Other – describe

…………………………………

…. No symptoms

…. Minor symptoms

…. Some restriction in lifestyle but independent

…. Dependent, but not requiring constant attention

…. Fully dependent, requiring attention day and night

4. MANAGEMENT 7. TRANSFUSION

a) Days in Intensive Care Unit (if not admitted to ICU, write ‘0’ here) a) Blood products transfusion YES NO

b) Significant Head Injury YES NO b) Units transfused in 28 days

c) Operation site - Tick one box on every line • Red cell products units

• Neurosurgical YES NO • Fresh frozen plasma units

• Chest YES NO • Platelets units

• Abdomen YES NO • Cryoprecipitate units

• Pelvis YES NO

• Recombinant Factor VIIa YES NO

5. COMPLICATIONS 8. PERSON COMPLETING FORM

Tick one box on every line NAME

• Pulmonary Embolism YES NO POSITION

• Deep Vein Thrombosis YES NO DATE

• Stroke YES NO

• Operation for bleeding YES NO

• Myocardial Infarction YES NO

• Gastrointestinal bleeding YES NO

6. TRIAL TREATMENT

a) Complete loading dose given YES NO

b) Complete maintenance dose given YES NO

NOW SEND THIS FORM TO THE CO-ORDINATING

CENTRE IN ONE OF THE FOLLOWING WAYS: • SECURE WEBSITE • ELECTRONIC DATA FORMS / EMAIL • FAX +44 (0)20 7299 4663 SEE INSTRUCTIONS IN YOUR SITE FILE

ISRCTN86750102

(Hospital name or code)

Attach treatment

pack sticker here



danarTi 4

kvlevis oqmis Sejameba

menejmentis jgufi Pprofesori tim koutsi (travmis menejmenti)

eqimi beverli hunti (hematologia da fibrinolizi)

Pprofesori ian robertsi (klinikuri kvlevebi)

Mq-ni haleema Sakuri (kvlevis menejeri)

q-ni barbara fareli (klinikuri kvlevebi)

Deqimi fil edvardsi (statistika)

Mq-ni maria ramosi (administratori)

CRASH kvlevis koordinaciuli centri londonis higienisa da tropikuli medicinis skola kepelis quCa, londoni WC1E 7HT tel +44(0)20 7299 4684 faqsi +44(0)20 7299 4663 el-fosta [email protected] WWW.CRASH2.LSHTM.AC.UK ISRCTN86750102

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