The Use of the Hemobag®

to Improve Clinical Outcomes in

any Blood Management Program

Keith A. Samolyk CCP, LCPGlobal Blood Resources LLC

WWW.MYBLOODFIRST.COMWWW.MYBLOODFIRST.COM

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Roadmap

Factors affecting transfusion decisions

Blood conservation techniques

Ways to reverse hemodilution

Ultrafiltration / Hemoconcentration

The Hemobag® – how it works

Clinical trial of the Hemobag® Flagship cases

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What drives transfusion decisions?

6,980 CABG patients

Significant association:

Hctlowest & death

IABP & return to CPB

No association:

Hctlowest and stroke

NNECDSG 1998

Surgeon (56%)

Patient Variables (35%)

Disease Variables (9%)

Age, sex, BSA, comorbidity score

LVEDP, EF, LM stenosis, # diseased vessels, lowest Hct on CPB vs. adverse outcomes

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Lowest Hct on CPB vs Adverse Outcomes6,980 CABG patients

Significant association

Hctlowest & death

IABP & return to CPB

No association

Hctlowest & stroke

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1

2

3

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<19 19-20 21-22 23-24 >25

Lowest Hct on CPB

Ad

just

ed M

ort

alit

y

NNECDSG(Defoe 2000)

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Managing anemia with transfusion after CPB increases mortality

10,178 CABG patients

If Hct < 22% & raised with transfusion...

Mortality directly Mortality directly influenced by influenced by transfusiontransfusion

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1

2

3

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6

7

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<22 22-24 24-26 >26

<21>21

NNECDSG

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During ECC18- 21% { normal risk patients } 21- 25% { high-risk patients during bypass }

Post-OperativelyAdequate oxygen delivery decreases morbidity & mortality22-25% { normal risk patients }25-30% { high-risk patients }

Jehovah's Witness patients Remarkable tolerance of severe acute normovolemic anemia

Tight adherence to specific guideline

Most cases can be performed without using allogeneic bloodwithout using allogeneic blood and a HCT above min.

Minimum Accepted Hematocrit Levels

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Typical Blood Conservation Techniques Used Today

Acute Normovolemic Hemodilution (ANH)

Hemodilution with crystalloid solutions

Intraoperative Autologous Donation (IAD)

Cell Saver for Shed Blood and Conservation

Apheresis / Platelet Gel / PRP

Ultrafiltration (Hemoconcentration), HemobagUltrafiltration (Hemoconcentration), Hemobag®®

Autotransfusion of unprocessed Shed Blood

from chest tube collection drains

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Blood Conservation Techniques for ECCMinimize circuit prime by

Condensing circuit to accommodate priming volume of ~1100 mL – 1400 mL

Smaller volume increases risk of micro-air, poor air handling qualities, and less reaction time

Retrograde Autologous Prime (RAP)***Displace crystalloid prime with patients own whole bloodpatients own whole blood

slow controlled exsanguination (1000 mL or more) team support of Anesthesia short acting vasoconstrictors like Neosynepherine

Can be done for freefree and is very cost effective

Closed Biocompatible/Heparin Coated Systems/SMC Reduce surface activation of bloodAir is foreign surface

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Total Body Water Increase leads to:Total Body Water Increase leads to:Tissue edema & cellular/organ dysfunction

Prolonged ventilatory support

Pulmonary hypertension

Decreased lung compliance

Coagulopathy

Anesthesia may give 1-4 L perioperatively For every 1L of crystalloid given only 250 mL remain intravascular

It’s not just ECC that contributes to hemodilutionIt’s not just ECC that contributes to hemodilution

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Average Circuit Volume is ~ 1200–1600mL

Retrograde Auto Priming for free canreduce circuit prime volume to ~ 500–800 mL or less

while maintaining a safe and trusted circuit

helping to eliminate hemodilution hemodilution

How else can we reverse HemodilutionHow else can we reverse Hemodilution ? ?

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Answer:Answer: Hemoconcentraters Hemoconcentraters

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Positive Effects of Ultrafiltration/Hemoconcentration

Removes noncellular H20

Decreases total body H20 concentrating WB

Increases Hctplatelets & clotting factorsalbumin & plasma proteins

Removes cytokines & anaphylatoxins

C3a, C5aIL6, IL8, TNF-AET-1, bradykininsadhesion moleculessE-Selectin

Improves organ fcnmyocardial fcn

cerebral oxygenation

pulmonary compliance

Reduces post-op blood loss

reduces transfusions

Reduces perioperative morbidity

Naik, 1991, Hospital for the Sick, Great Ormond St. UK

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Benefits of MUFMUF increases

Post CPB Hct

Systolic and diastolic pressure

Cardiac Index

Myocardial contractility

Red cell mass

Pulmonary compliance

Arterial oxygenation

Cerebral oxygenation

Left ventricular function

Diastolic compliance

Plasma proteins

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Heart rate & PVR

Myocardial wall thickness

Pulmonary hypertension

Incidence of effusions

Intrapulmonary shunt fraction

24 hr blood loss

Inotrope requirement

Blood product usage

TBW content

Hospital stay

Ultrafiltration combats Hemodilution

MUF decreases

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How does it happen?

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Permeability varies with type of capillary

Capillary type varies with organ function

1. Tight (brain) 2. Continuous (skeletal muscle, skin) 3. Fenestrated (secretory glands, kidney, gut) 4. Discontinuous (liver, spleen, bone marrow)

Capillary "Type"

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Edema:Edema: Most common clinical manifestation of

an imbalance of forces at the capillary wall Excess accumulation of fluid in the interstitial space that has not

been readsorbed into capillaries or taken up by the lymphatics

Causes includeObstruction Permeability or change in reflection coefficient

Increased protein permeability results in an imbalance Occurs in trauma, thermal injury, inflammationLife threatening manifestations - endotoxic shock, ARDS

Plasma ProteinReduction in circulating plasma proteins, especially albuminLiver dysfunction, malnutrition, or acute alteration of fluid status

Albumin attenuates extravasation of fluid out of intravascular space to interstitial space

Capillary pressure

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How can we get these positive effects of HEMOCONCENTRATIONHEMOCONCENTRATION?

Naik, 1991, Hospital for the Sick, Great Ormond St. UK

Removes noncellular H20

Decreases total body H20

concentrating WB

Increases Hct

Platelets & clotting factors

Albumin & plasma proteins

Removes cytokines & anaphylatoxins

Improves organ fcnmyocardial fcn

cerebral oxygenation

pulmonary complianceReduces post-op blood loss reduces transfusions

Reduces perioperative morbidity

A New Technology for Blood Management is the

HEMOBAGHEMOBAG®®

A Universal Blood Reservoir for

Salvaging Autologous Whole Blood

from ECC’s

• Specially designed for quickly– Filling– Hemoconcentrating–Transfusing – All in the same Hemobag®

• Doubles use of any Hemoconcentrator

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TS3 Tubing Set doubles the use of any Hemoconcentrator

For use both during the case

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And at the end of the case forWhole Blood Salvaging of the ECC Circuit

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HEMOBAG® SUMMARYHEMOBAG® SUMMARY

25“Your Body Your Choice” pg. 26, S.Farmer and D. Webb

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The Big Picture

Choices/ Alternatives Publication Vol 4 Issue 2, Center for Bloodless Medicine and Surgery, University of Miami / Jackson Med Ctr.

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Salvaged Blood with a Cell Saver

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Blood Salvaged with the Hemobag®

Everything that’s Autologous is Concentrated and given back for stability and Homeostasis

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21.4

53.1

2.68.2 92

305.8

186

266

1 2 3 4 Hct % Total Protein g/dl Fibrinogen mg/dl Platelet Count K/ul

Pre- and Post- Hemobag Blood Components

Pre-Hemobag

Post-Hemobag

Average change in blood parameters:

Pre-Hemobag Post-HemobagHCT 21.4% 53.1%Total Protein 2.6 g/dL 8.2 g/dL Fibrinogen 92 mg/dL 305.8 mg/dLPlatelet Conc. 186 K/uL 266 K/uL

Data from 40 Patients’ ECCs

chased with 2.0 L of crystalloid filling the Hemobag®

Salem Hospital, Salem Oregon

Ave. volume returned = 820 mL

Average time toFill the Hemobag®: 60 sec +/- 20 sec

Hemoconcentrate contents of the Hemobag® (2L1L):

10.5 min +/- 1 min (total = 11.5 min +/- 80 sec)

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155

364

221

740

2357

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300

400

500

600

700

800

Plt. Ct. k/cumm Fibrinogen mg/dl HCT %

Change in Blood Parameters

Patient Hemobag

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10

15

Change in Protein Levels

Patient 2.3 4

Hemobag 6.6 11.7

Albumin gm/dl Total Protein gm/dl

Results represent what is possible with the

Hemobag®

FLAGSHIP CASE #1:FLAGSHIP CASE #1:Over 80y/o female, AVR case, post-op bleeding: 300mL, left ICU post-op Day #1, no blood products given

Reinfused 900 mL Conc. 900 mL Conc. Autologous Whole BloodAutologous Whole Blood from CPB circuit with:

Hct = 57%

Platelets = 364 K

Fibrinogen = 740 mg

Albumin = 6.6 g/dL

Total protein = 11.7 g/dL

Time: 12 minutes

Extracorporeal circuit kept viable & ready to go back emergently

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241

430292

972

26 56

0

200

400

600

800

1000

Plt. Ct. k/cumm Fibrinogen mg/dl HCT %

Change in Blood Parameters

Patient Hemobag

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5

10

15

Change in Protein Levels

Patient 2.1 4.1

Hemobag 5.7 13.6

Albumin gm/dl Total Protein gm/dl

FLAGSHIP CASE #2:FLAGSHIP CASE #2:60 yr old CABG x 3, post-op bleeding was 290 mL, left ICU on Post-op Day #1, no blood products given

Reinfused 1150 mL Conc. 1150 mL Conc. Autologous Whole BloodAutologous Whole Blood from CPB circuit with:

Hct = 56%

Platelets = 430 K

Fibrinogen = 972 mg

Albumin = 5.7 g/dL

Total protein = 13.6 g/dL

300% increase in FVII

73% activity to 223%

Time: 10 minutes

Extracorporeal circuit kept viable & ready to go back

Illustrates capabilities of the

Hemobag® when used for Whole Blood Salvaging in CV Surgery

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Both the Hemobag® and TS3 tubing set come 5 to a box and are sold together

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Sterile Peel Pouches

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Easy to Understand Directions

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Benefits Overview

CELL SAVER HEMOBAG®

If you were the patient wouldn’t you want all your own AUTOLOGOUS CELLS back first?

VS

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Conclusion about the Hemobag®

The Hemobag® system effectively Concentrates Extracorporeal Circuit contents Produces Autologous Whole Blood

high in RBC’s and plasma proteins

Offers advantages over current technology quick, easy, enhanced end product

“The Hemobag® is the Missing Piece in the Big Picture of

Blood Salvaging and Conservation”

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Bottom Line Life is related to blood and anything you can do to save more of a patient’s Own Whole Blood is better than anything else … Period !

Patients transfused with allogeneic blood products are exposed to a host of new potential complications

No one is exempt from resultant immunosuppression

The least of these is a mild form of TRALI which leads tolonger and delayed time to extubation & discharge from the ICU

increased risk of Morbidity and Mortality

Autologous whole blood is jugular for perfect natural homeostasis

We should be doing everything we can to conserve more of this precious substance

It’s in the Patient’s Best Interest - It’s the Right of all Patients

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Thank You for listening !Global Blood Resources LLC

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