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Does HBOC-201 (Hemopure) affect platelet function in orthopedic surgery: a single-site analysis from a multicenter
Jonathan S Jahr1, Hong Liu, Olga K Albert
1David Geffen School of Medicine at UCLA, Los Angeles, CA 90095-7403, USA. jsjahr@mednet.ucla.edu
American Journal of Therapeutics
|May 7, 2009
Summary
HBOC-201, a bovine hemoglobin-based oxygen carrier, was found to cause mild platelet dysfunction in a Phase III trial subset analysis. Platelet function tests showed significant changes after HBOC-201 infusion compared to packed red blood cells (PRBCs).
Area of Science:
- Biomedical research
- Hematology
- Pharmacology
Background:
- HBOC-201 (Hemoglobin glutamer-250, bovine) is a hemoglobin-based oxygen carrier evaluated in clinical trials.
- Understanding the impact of HBOC-201 on hemostasis, particularly platelet function, is crucial for its clinical application.
Purpose of the Study:
- To assess the effect of HBOC-201 on platelet function compared to packed red blood cells (PRBCs).
- To evaluate changes in platelet function at multiple time points before and after transfusion.
Main Methods:
- Subset analysis from a multicenter, pivotal Phase III trial of HBOC-201.
- Platelet function assessed using the PFA-100 assay (measuring closure times with epinephrine and ADP) in 27 subjects (12 HBOC-201, 15 PRBC).
- Comparison of platelet function at seven time points: baseline, pre-transfusion, post-transfusion, and days 1, 2, 3-9, and 21+ post-transfusion.
Main Results:
- No significant differences in platelet function between baseline and pre-transfusion measurements in either group.
- HBOC-201 group showed statistically significant increases in collagen-epinephrine (cEPI) and collagen-ADP (cADP) closure times post-transfusion compared to baseline and pre-transfusion values.
- The PRBC group exhibited no significant changes in cEPI or cADP closure times across all measured time points.
Conclusions:
- HBOC-201 administration is associated with mild, transient platelet dysfunction.
- While closure times increased and exceeded upper normal limits, they did not reach non-closure levels.
- Further controlled studies are warranted to definitively establish the clinical implications of HBOC-201 on platelet function.
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