TRANEXAMIC ACID FOR BLEEDING · Cerebrovascular disease (CVA with mild or no residual or TIA) ......

1 Tranexamic Acid final CRF 24.7.19

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CONFIDENTIAL CASE REPORT FORM

TRANEXAMIC ACID FOR BLEEDING

Series No: 24

Palliative Care Clinical Studies Collaborative (PaCCSC) RAPID Pharmacovigilance in Palliative Care

The case report form (CRF) is to be completed in compliance with PaCCSC Standard Operating Procedures (SOP)


Tranexamic Acid for Bleeding – Baseline (T0)

Demographics Gender Male Female

⃝ Other Age (yrs)

Weight (kg)

Height (cm)

What is the primary diagnosis?

⃝ Advanced metastatic cancer

⃝ Haematological disease– please specify below

□ Acute Leukemia □ Chronic Leukaemia

□ Lymphoma □ Bone marrow failure syndrome

□ Multiple Myeloma □ Myeloproliferative disorder (MPD)

□ Myelodysplasia (MDS)

□ Other bone marrow failure syndrome (e.g. aplastic anaemia)

□ Other haematological disorder-please specify__________________

⃝ Solid organ malignancy (non metastatic)

⃝ End stage renal failure

⃝ Hepatic failure

⃝ Other primary diagnosis; please specify_____________________________ Is this diagnosis life limiting:

Yes No If diagnosis is life limiting please specify Palliative Care Phase?

Stable Unstable Deteriorating Terminal

Stable: The person's symptoms are adequately controlled by established management. Further interventions to maintain symptom control and quality of life have been planned. Unstable Phase: The person experiences the development of a new problem or a rapid increase in the severity of existing problems either of which requires an urgent change in management or emergency treatment.

Deteriorating Phase: The person experiences a gradual worsening of existing symptoms or the development of new but expected problems. These require the application of specific plans of care and regular review but not urgent or emergency treatment.

Terminal Care Phase: Death is likely in a matter of days and no acute intervention is planned or required.


Laboratory Tests (in last 28 days only if available)

Date of Laboratory Tests (dd/mm/yyyy)

Test Value

Haemoglobin (Hb) g/L

Platelet count (x 109/L)

APTT prolonged (i.e. higher than upper limit of reference range)?

Yes □ No □

International Normalised Ratio (INR)

Creatinine (micromol/L)

Fibrinogen (g/L)

Serum Albumin (g/dL)

Is patient currently on any anticoagulant/antiplatelet medication? (If yes please specify below) ⃝ Yes ⃝ No

Specify anticoagulation/antiplatelet medication here

□ heparin

□ warfarin (Coumadin)

□ rivaroxaban (Xarelto)

□ dabigatran (Pradaxa)

□ apixaban (Eliquis)

□ edoxaban (Savaysa)

□ enoxaparin (Lovenox)

□ fondaparinux (Arixtra)

□ aspirin

□ clopidogrel

□ prasugrel

□ ticagrelor

□ dipyridamole

□ Other – please specify


Australian Modified Karnofsky Performance Scale (AKPS)

100 Normal; no complaints; no evidence of disease

90 Able to carry on normal activity; minor signs of symptoms

80 Normal activity with effort; some signs of symptoms or disease

70 Cares for self; unable to carry on normal activity or to do active work

60 Requires occasional assistance but is able to care for most of his needs

50 Requires considerable assistance and frequent medical care

40 In bed more than 50% of the time

30 Almost completely bedfast

20 Totally bedfast and requiring extensive nursing care by professionals and/or family

10 Comatose or barely rousable

0 Dead

Not able to determine

Charlson Comorbidity Index Does patient have any of the following?

□ Myocardial infarction (history, not ECG changes only)

□ Congestive cardiac failure

□ Peripheral vascular disease (includes aortic aneurysm >= 6 cm)

□ Cerebrovascular disease (CVA with mild or no residual or TIA)

□ Hemiplegia

□ Dementia

□ Chronic pulmonary disease

□ Connective tissue disease

□ Peptic ulcer disease

□ Leukaemia (acute or chronic)

□ Lymphoma

□ AIDS (not just HIV positive)

□ Moderate or severe renal disease

□ Any tumour without metastasis (exclude if > 5 y from diagnosis)

□ Metastatic solid tumour

□ Diabetes (without organ damage) (excludes diet-controlled alone)

□ Diabetes with end organ damage

□ Mild liver disease (without portal hypertension, includes chronic hepatitis)

□ Moderate or severe liver disease


Does patient have a past history of seizures? ⃝ Yes ⃝ No

Has patient had a platelet transfusion in the last month? ⃝ Yes ⃝ No

If yes please record date of the most recent platelet transfusion (dd/mm/yyyy)

Is there a past history of venous thrombosis (including DVT/PE)? ⃝ Yes ⃝ No

Is there a past history of arterial thrombosis (including myocardial infarction or ischaemic stroke)? ⃝ Yes ⃝ No


Baseline – T0-Medication Commencement Date of Baseline dd/mm/yyyy

DOSING SCHEDULE: Initial dose Tranexamic Acid (mg)

Frequency of dose ⃝ Daily ⃝ BD ⃝ TDS ⃝ QID ⃝ Other-please specify_____________

Route ⃝ IV ⃝ Oral ⃝ Other-please specify_____________

Time of initial dose (in 24hr clock e.g. 2200)

Is patient also using topical Tranexamic acid? ⃝ Yes - if yes please indicate below which topical is being used below. ⃝ No

⃝ Mouthwash ⃝ Wound ⃝ Other-please specify: _________________________

Is patient receiving Tranexamic acid for active bleeding or prophylaxis? (tick all that apply) ⃝ Active bleeding (please complete bleeding assessment below)

⃝ Prophylaxis

⃝ Prophylaxis prior to procedure

Other measures (if any) to stop bleeding, e.g. platelet transfusion, red cell transfusion, stopping anticoagulants, surgery, endoscopy


SYMPTOM SEVERITY Bleeding

0 1 2 3 4 Grade 1: • Petechiae, oropharyngeal bleeding, • Epistaxis (<1 hour), • Purpura < 1” diameter, • Stool occult blood (trace to 1+) • Urine haemoglobin (trace to 1+), • Retinal haemorrhage without visual, impairment. • Abnormal vaginal bleeding Grade 2: • Melaena, hematemesis, haemoptysis,, haematuria, hematochezia, and abnormal vaginal bleeding not requiring RBC Tx • Epistaxis or oropharyngeal bleeding >1 hour. • Stool occult blood (moderate or 2+ and greater), • Urine haemoglobin (moderate or 2+ and greater) Grade 3: • Melaena, hematemesis,, haemoptysis, haematuria, abnormal, vaginal bleeding, haematochezia,, epistaxis, and oropharyngeal bleeding requiring RBC Tx, • Bleeding from invasive sites • CNS bleeding noted on CT without clinical consequences. Grade 4: • Debilitating bleeding including retinal bleeding with visual impairment,, non-fatal CNS bleeding with neurologic signs and symptoms, bleeding associated with haemodynamic instability, and fatal bleeding from any source.

BLEEDING ASSESSMENT

Was there mucosal bleeding (nose, throat, mouth or subconjunctiva)? □ YES □ NO

Did patient have any skin bleeding? (petechiae/purpura/ecchymoses) □ YES □ NO Does patient have bleeding from the lungs: haemoptysis (coughing up blood) OR seen on investigation OR scan? □ YES □ NO Any haematuria (blood in urine) or any bleeding into the renal tract?

□ YES □ NO Did patient have any abnormal vaginal bleeding?

□ YES □ NO Did the patient have retinal or vitreous haemorrhage (examination by physician)? □ YES □ NO Did patient have gastrointestinal bleeding (visible blood in stool, melaena or haematemesis)? □ YES □ NO Did patient have bleeding from invasive procedure site?

□ YES □ NO Did the patient have intracranial bleeding confirmed by objective method (blood in CSF (non traumatic tap) or imaging study? □ YES □ NO Did the patient have any soft tissue haematomas or joint bleeding? □ YES □ NO Did the patient have any other bleeding in or around an organ?

□ YES □ NO - Which organ?

Did the patient have fatal or life threatening bleeding?

□ YES □ NO


T0- Baseline Harms/Symptom assessment (prior to commencement of medication) Nausea

1 2 3 ungradable no symptom

NCI Criteria 1. Loss of appetite without alteration in eating habits 2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.

Vomiting

1 2 3 4 5 Ungradable No Symptom

NCI Criteria 1. 1 - 2 episodes (separated by 5 minutes) in 24 hrs 2. 3 - 5 episodes (separated by 5 minutes) in 24 hrs 3. >=6 episodes (separated by 5

minutes) in 24 hrs; tube feeding, TPN or hospitalization indicated 4. Life-threatening consequences; urgent intervention indicated 5.Death

Diarrhoea


NCI Criteria 1. Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline 2. Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline 3. Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4. Life-threatening consequences; urgent intervention indicated 5. Death

Thrombosis (current)

□ Venous □ Arterial □ Neither

1 2 3 4 5 ungradable no symptom

NCI Criteria 1.Venous thrombosis (e.g., superficial thrombosis, not requiring medical intervention) 2. Venous thrombosis (e.g., uncomplicated deep vein thrombosis), medical intervention indicated 3. Venous or arterial thrombosis (e.g., uncomplicated pulmonary embolism [venous], nonembolic cardiac mural [arterial] thrombus), medical intervention indicated 4. Life-threatening (e.g., pulmonary embolism, cerebrovascular event, arterial insufficiency); hemodynamic or neurologic instability; urgent intervention indicated 5. Death

Seizures


NCI Criteria 1. Seizure Brief partial seizure; no loss of consciousness

2. Brief generalized seizure 3. Multiple seizures despite medical intervention 4. Life-threatening; prolonged repetitive seizures 5. Death


Other (if exists) Please specify other toxicity here ____________________________ Additional other (if exists) Please specify additional other toxicity here ______________ Which symptom/harm is the most troublesome?

⃝ Nausea

⃝ Vomiting

⃝ Diarrhoea ⃝ Thrombosis

⃝ Seizures

⃝ Other

⃝ Additional other ⃝ Not applicable


T1 – 24 – 72hrs hours post Baseline T1: Assessed/Not assessed reason ⃝ Assessed today (continue to complete T1) OR

⃝ Died

⃝ Not able to be contacted / located

⃝ Too unwell

⃝ Other Date of Death dd/mm/yyyy

Cause of Death

End Survey here Date and Time of Assessment

dd/mm/yyyy

00:00 24hr time

If today’s date of assessment is not 24-72hrs after the Baseline date of assessment please provide the reason below

Total dose of Tranexamic acid given in the last 24 hours (mg)

How long has the patient been on this dose (days)

Based on your assessment at this time was there any benefit?

Yes ⃝ No ⃝ Does patient have any active bleeding? Yes ⃝ (please complete bleeding assessment) No ⃝ Other measures (if any) to stop bleeding, e.g. platelet transfusion, red cell transfusion, stopping anticoagulants, surgery, endoscopy




BLEEDING ASSESSMENT


Did patient have any skin bleeding? (petechiae/purpura/ecchymoses) □ YES □ NO Does patient have bleeding from the lungs: haemoptysis (coughing up blood) OR seen on investigation OR scan? □ YES □ NO Any haematuria (blood in urine) or any bleeding into the renal tract?






□ YES □ NO


T1- Harm Assessment Nausea


NCI Criteria 1.loss of appetite without alteration in eating habits 2. Oral intake decreased without significant weight loss. 3. Inadequate caloric or fluid intake; tube feeding, TPN or hospitalisation indicated.

Vomiting




Diarrhoea


NCI Criteria 1. Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline

2. Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline 3. Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4. Life-threatening consequences; urgent intervention indicated 5. Death





Seizures

1 2 3 4 5 Ungradable No Symptom NCI Criteria 1. Seizure Brief partial seizure; no loss of consciousness 2. Brief generalized seizure 3. Multiple seizures despite medical intervention 4. Life-threatening; prolonged repetitive seizures 5. Death


Other (if exists) Please specify other harm here ____________________________ Additional other (if exists) Please specify additional other harm here ______________ Which harm is the most troublesome?

⃝ Nausea

⃝ Vomiting


⃝ Seizures

⃝ Other


Key questions derived from the Naranjo modified check list (only complete if a harm (excluding bleeding) symptom scores 3 or more) 1. Did the adverse reaction appear after the suspected drug was given?

⃝ Yes

⃝ No

⃝ Don’t know

2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?

⃝ Yes

⃝ No

⃝ Don’t know 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction?

⃝ Yes

⃝ No

⃝ Don’t know

4. Did the patient have a similar reaction to the same or similar drug in any previous exposure?

⃝ Yes

⃝ No

⃝ Don’t know


5. Was the adverse event confirmed by any objective evidence?

⃝ Yes

⃝ No

⃝ Don’t know Post harms assessment What is the intended treatment based on today’s assessment?

⃝ No change to medication of interest/continue current dose

⃝ Medication of interest ceased

⃝ Medication of interest reduced

⃝ Medication of interest increased – please specify dose What is the increased dose after assessment?

mgs

Has a medication been added to treat a specific harm? Yes ⃝ No ⃝ If yes please specify medication.

Based on the assessment today has the harm resolved?

Yes ⃝ No ⃝ N/A ⃝

Date of planned next visit

dd/mm/yyyy


T2 – 7-14 days post Baseline T2: Assessed/Not assessed reason

⃝ Assessed today (continue to complete T1) OR

⃝ Died

⃝ Not able to be contacted / located

⃝ Too unwell

⃝ Other Date of Death dd/mm/yyyy

Cause of Death

End Survey here Date of and Time of Assessment

dd/mm/yyyy

00:00 24hr time

If today’s date of assessment is not 7-14 days after the Baseline date of assessment please provide the reason below

Total dose of Tranexamic Acid given in the last 24 hours (mg)

How long has the patient been on this dose (days)

Based on your assessment at this time was there any benefit? Yes ⃝ No ⃝ Does patient have any active bleeding? Yes ⃝ (please complete bleeding assessment) No ⃝ Other measures (if any) to stop bleeding, e.g. platelet transfusion, red cell transfusion, stopping anticoagulants, surgery, endoscopy




BLEEDING ASSESSMENT


Did patient have any skin bleeding?

(petechiae/purpura/ecchymoses) □ YES □ NO Does patient have bleeding from the lungs: haemoptysis (coughing up blood) OR seen on investigation OR scan? □ YES □ NO Any haematuria (blood in urine) or any bleeding into the renal tract?






□ YES □ NO


T2-Harms Assessment Nausea



Vomiting




Diarrhoea


NCI Criteria 1. Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline

2. Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline 3. Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4. Life-threatening consequences; urgent intervention indicated 5. Death





Seizures


NCI Criteria 1. Seizure Brief partial seizure; no loss of consciousness 2. Brief generalized seizure 3. Multiple seizures despite medical intervention 4. Life-threatening; prolonged repetitive seizures 5. Death



⃝ Nausea

⃝ Vomiting


⃝ Seizures

⃝ Other


Key questions derived from the Naranjo modified check list (only complete if a harm (excluding bleeding) scores 3 or more) 1. Did the adverse reaction appear after the suspected drug was given?

⃝ Yes

⃝ No

⃝ Don’t know

2. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was given?

⃝ Yes

⃝ No

⃝ Don’t know 3. Are there alternative causes (other than the drug) that could on their own have caused the reaction?

⃝ Yes

⃝ No

⃝ Don’t know 4. Did the patient have a similar reaction to the same or similar drug in any previous exposure?

⃝ Yes

⃝ No

⃝ Don’t know


5. Was the adverse event confirmed by any objective evidence?

⃝ Yes

⃝ No

⃝ Don’t know Post harms assessment What is the intended treatment based on today’s assessment?

⃝ No change to medication of interest/continue current dose

⃝ Medication of interest ceased

⃝ Medication of interest reduced

⃝ Medication of interest increased – please specify dose What is the increased dose after assessment?

mgs

Has a medication been added to treat a specific harm?

Yes ⃝ No ⃝ If yes please specify medication.

Based on the assessment today has the harm resolved?

Yes ⃝ No ⃝ N/A ⃝


Medication Cessation (complete this page at any time the medication of

interest is ceased) Date of assessment dd/mm/yyyy

Medication was ceased (related to indication of interest):

⃝ Symptom resolved

⃝ Symptom worsened

⃝ Symptom continued unchanged Medication was ceased (related to other reasons):

⃝Toxicity/harm

⃝ Patient unable to take medication

⃝ Other What treatment did you subsequently initiate following the cessation of the medication of interest? Symptom resolved – date of resolution dd/mm/yyyy

Symptom worsened (NCI grade)

⃝ 1 ⃝ 2 ⃝ 3 ⃝ 4 ⃝ 5 Please specify the ‘other’ reason medication was ceased

Please specify the patient’s inability to take medication


Adhoc A - Unscheduled adverse events/harms - Please complete the survey below. Please list any harms that occur regardless of whether they are attributable to the medication of interest or not. Were there any unscheduled adverse events/harms?

Yes No Date of assessment dd/mm/yyyy

Harms Assessment Nausea



Vomiting




Diarrhoea


NCI Criteria 1. Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline 2. Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline

3. Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL 4. Life-threatening consequences; urgent intervention indicated 5. Death




NCI Criteria 1.Venous thrombosis (e.g., superficial thrombosis, not requiring medical intervention) 2. Venous thrombosis (e.g., uncomplicated deep vein thrombosis), medical intervention indicated 3. Venous or arterial thrombosis (e.g., uncomplicated pulmonary embolism [venous], nonembolic cardiac

mural [arterial] thrombus), medical intervention indicated 4. Life-threatening (e.g., pulmonary embolism, cerebrovascular event, arterial insufficiency); hemodynamic or neurologic instability; urgent intervention indicated 5. Death


Seizures




⃝ Nausea

⃝ Vomiting


⃝ Seizures

⃝ Other

⃝ Additional other


Adhoc B – Unscheduled adverse events / harms - Please complete the survey below. Please list any harms that occur regardless of whether they are attributable to the medication of interest or not Were there any unscheduled adverse events/harms?





Vomiting




Diarrhoea


NCI Criteria 1. Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline 2. Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline 3. Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in

ostomy output compared to baseline; limiting self-care ADL 4. Life-threatening consequences; urgent intervention indicated 5. Death







Seizures 1 2 3 4 5 Ungradable No Symptom



⃝ Nausea

⃝ Vomiting


⃝ Seizures

⃝ Other



Adhoc C Unscheduled adverse events/ harms- Please complete the survey below. Please list any harms that occur regardless of whether they are attributable to the medication of interest or not Were there any unscheduled adverse events/harms?





Vomiting




Diarrhoea


NCI Criteria 1. Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline 2. Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline 3. Increase of >=7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in

ostomy output compared to baseline; limiting self-care ADL 4. Life-threatening consequences; urgent intervention indicated 5. Death







Seizures 1 2 3 4 5 Ungradable No Symptom



⃝ Nausea

⃝ Vomiting


⃝ Seizures

⃝ Other


TRANEXAMIC ACID FOR BLEEDING · Cerebrovascular disease (CVA with mild or no residual or TIA) ......

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Transcript of TRANEXAMIC ACID FOR BLEEDING · Cerebrovascular disease (CVA with mild or no residual or TIA) ......