1. Global Blood Resources LLC
The Use of the Hemobag® to Improve Clinical Outcomes in any Blood Management Program
Keith A. Samolyk CCP, LCP
Global Blood Resources LLC

2. 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

3. What drives transfusion decisions?
LVEDP, EF, LM stenosis, # diseased vessels, lowest Hct on CPB vs. adverse outcomes
6,980 CABG patients
Significant association:
Hctlowest & death
IABP & return to CPB
No association:
Hctlowest and stroke
Disease Variables (9%)
Surgeon (56%)
Age, sex, BSA, comorbidity score
Patient Variables (35%)
NNECDSG 1998

4. Lowest Hct on CPB vs Adverse Outcomes 6,980 CABG patients
Significant association
Hctlowest & death
IABP & return to CPB
No association
Hctlowest & stroke
Adjusted Mortality
Lowest Hct on CPB
NNECDSG(Defoe 2000)

5. Managing anemia with transfusion after CPB increases mortality 10,178 CABG patients
If Hct < 22% & raised with transfusion...
Mortality directly influenced by transfusion
NNECDSG

6. Minimum Accepted Hematocrit Levels
During ECC
18- 21% { normal risk patients }
21- 25% { high-risk patients during bypass }
Post-Operatively
Adequate oxygen delivery decreases morbidity & mortality
22-25% { 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 blood and a HCT above min.

7. 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), Hemobag®
Autotransfusion of unprocessed Shed Blood
from chest tube collection drains

8. Blood Conservation Techniques for ECC
Minimize 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 blood
slow controlled exsanguination (1000 mL or more)
team support of Anesthesia
short acting vasoconstrictors like Neosynepherine
Can be done for free and is very cost effective
Closed Biocompatible/Heparin Coated Systems/SMC
Reduce surface activation of blood
Air is foreign surface

9. It’s not just ECC that contributes to hemodilution
Anesthesia may give 1-4 L perioperatively For every 1L of crystalloid given only 250 mL remain intravascular
Total Body Water Increase leads to:
Tissue edema & cellular/organ dysfunction
Prolonged ventilatory support
Pulmonary hypertension
Decreased lung compliance
Coagulopathy
It’s not just ECC that contributes to hemodilution

10. Average Circuit Volume is ~ 1200–1600mL
Retrograde Auto Priming for free can
reduce circuit prime volume to ~ 500–800 mL or less
while maintaining a safe and trusted circuit
helping to eliminate hemodilution
How else can we reverse Hemodilution ?

11. Answer: Hemoconcentraters

12. Positive Effects of Ultrafiltration/Hemoconcentration
Removes noncellular H20
Decreases total body H20
 concentrating WB
Increases
Hct
platelets & clotting factors
albumin & plasma proteins
Removes cytokines & anaphylatoxins
C3a, C5a
IL6, IL8, TNF-A
ET-1, bradykinins
adhesion molecules
sE-Selectin
Improves organ fcn
myocardial 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

13. Benefits of MUF MUF 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

14. Ultrafiltration combats Hemodilution
MUF decreases
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

15. How does it happen?

17. Capillary "Type" 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)

18. 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 include
Obstruction
Permeability or change in reflection coefficient
Increased protein permeability results in an imbalance
Occurs in trauma, thermal injury, inflammation
Life threatening manifestations - endotoxic shock, ARDS
Plasma Protein
Reduction in circulating plasma proteins, especially albumin
Liver dysfunction, malnutrition, or acute alteration of fluid status
Albumin attenuates extravasation of fluid out of intravascular space to interstitial space
Capillary pressure

20. How can we get these positive effects of HEMOCONCENTRATION?
Removes noncellular H20
Decreases total body H20
 concentrating WB
Increases
Hct
Platelets & clotting factors
Albumin & plasma proteins
Removes cytokines & anaphylatoxins
Improves organ fcn
myocardial 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

21. A New Technology for Blood Management is the HEMOBAG®
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

22. TS3 Tubing Set doubles the use of any Hemoconcentrator
For use both during the case

23. And at the end of the case for Whole Blood Salvaging of the ECC Circuit

24. HEMOBAG® SUMMARY
HEMOBAG® SUMMARY

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

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

27. Salvaged Blood with a Cell Saver

28. Blood Salvaged with the Hemobag®
Everything that’s Autologous is Concentrated and given back for stability and Homeostasis

29. Data from 40 Patients’ ECCs
chased with 2.0 L of crystalloid filling the Hemobag®
Average time to
Fill the Hemobag®: 60 sec +/- 20 sec
Hemoconcentrate contents of the Hemobag® (2L1L):
10.5 min +/- 1 min (total = 11.5 min +/- 80 sec)
Average change in blood parameters:
Pre-Hemobag Post-Hemobag
HCT % %
Total Protein g/dL g/dL
Fibrinogen mg/dL mg/dL
Platelet Conc K/uL K/uL
Salem Hospital, Salem Oregon
Ave. volume returned = 820 mL

30. Results represent what is possible with the Hemobag®
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. Autologous 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
Results represent what is possible with the Hemobag®

31. 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. Autologous 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

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

33. Sterile Peel Pouches

34. Easy to Understand Directions

35. Benefits Overview CELL SAVER VS HEMOBAG®
If you were the patient wouldn’t you want all your own AUTOLOGOUS CELLS back first?

36. 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”

37. 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 to
longer 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

38. Thank You for listening ! Global Blood Resources LLC