Abstract
HBOC-201, Hemoglobin glutamer-250 (bovine), (Biopure Corp., Cambridge, MA) has been studied in an international, multicenter, pivotal Phase III trial. A subset analysis of use of blood products indicated that the HBOC-201 group required no more than the packed red blood cell (PRBC) group and was limited to less than 6% in both treatment groups. In a subset analysis from one site, platelet function using PFA-100 was assessed before and after transfusion, and compared those receiving HBOC-201 versus PRBC. After initial IRB approval, patient consent for the Phase III trial and blood draws for PFA-100, an additional IRB exemption for retrospective chart review was obtained. cEPI and cADP means were compared at seven time periods: true baseline(before starting surgery and anesthesia), before transfusion, after transfusion, 1 day, 2 days, 3 to 9 days and 21 or more days after transfusion. Twenty-seven (HBOC: n = 12, PRBC: n = 15) subjects were studied. Comparing data from before transfusion and baseline did not show statistically significant differences in any of cEPI or cADP measurements. cEPI means for the HBOC-201 group increased after transfusion compared to the true baseline (P = 0.01), before transfusion (P = 0.0004) and day 1 after transfusion (P = 0.002). cADP means for the HBOC-201 group were greater after transfusion compared to the true baseline (P = 0.05) and before transfusion (P = 0.005). In the PRBC group there were no significant difference in cEPI and cADP means between all of the time periods. Our study shows that HBOC-201 causes mild platelet dysfunction. Although there were significant changes after HBOC infusion and cEPI and cADP mean values were above the upper normal limit, they did not reach the non-closure time. Further controlled studies are needed to establish definitively the effects that HBOC-201 has on platelet function in patients.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 140-147 |
| Number of pages | 8 |
| Journal | American Journal of Therapeutics |
| Volume | 17 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 2010 |
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Keywords
- HBOC-201
- Hemoglobin-based oxygen carrier
- Hemoglobin-glutamer 250 (bovine)
- Hemopure
- PFA-100
- Platelet dysfunction
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
Cite this
Does HBOC-201 (hemopure) affect platelet function in orthopedic surgery : A single-site analysis from a multicenter study. / Jahr, Jonathan S.; Liu, Hong; Albert, Olga K.; Gull, Amy; Moallempour, Mojgan; Lim, Jennifer; Gosselin, Robert.
In: American Journal of Therapeutics, Vol. 17, No. 2, 03.2010, p. 140-147.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Does HBOC-201 (hemopure) affect platelet function in orthopedic surgery
T2 - A single-site analysis from a multicenter study
AU - Jahr, Jonathan S.
AU - Liu, Hong
AU - Albert, Olga K.
AU - Gull, Amy
AU - Moallempour, Mojgan
AU - Lim, Jennifer
AU - Gosselin, Robert
PY - 2010/3
Y1 - 2010/3
N2 - HBOC-201, Hemoglobin glutamer-250 (bovine), (Biopure Corp., Cambridge, MA) has been studied in an international, multicenter, pivotal Phase III trial. A subset analysis of use of blood products indicated that the HBOC-201 group required no more than the packed red blood cell (PRBC) group and was limited to less than 6% in both treatment groups. In a subset analysis from one site, platelet function using PFA-100 was assessed before and after transfusion, and compared those receiving HBOC-201 versus PRBC. After initial IRB approval, patient consent for the Phase III trial and blood draws for PFA-100, an additional IRB exemption for retrospective chart review was obtained. cEPI and cADP means were compared at seven time periods: true baseline(before starting surgery and anesthesia), before transfusion, after transfusion, 1 day, 2 days, 3 to 9 days and 21 or more days after transfusion. Twenty-seven (HBOC: n = 12, PRBC: n = 15) subjects were studied. Comparing data from before transfusion and baseline did not show statistically significant differences in any of cEPI or cADP measurements. cEPI means for the HBOC-201 group increased after transfusion compared to the true baseline (P = 0.01), before transfusion (P = 0.0004) and day 1 after transfusion (P = 0.002). cADP means for the HBOC-201 group were greater after transfusion compared to the true baseline (P = 0.05) and before transfusion (P = 0.005). In the PRBC group there were no significant difference in cEPI and cADP means between all of the time periods. Our study shows that HBOC-201 causes mild platelet dysfunction. Although there were significant changes after HBOC infusion and cEPI and cADP mean values were above the upper normal limit, they did not reach the non-closure time. Further controlled studies are needed to establish definitively the effects that HBOC-201 has on platelet function in patients.
AB - HBOC-201, Hemoglobin glutamer-250 (bovine), (Biopure Corp., Cambridge, MA) has been studied in an international, multicenter, pivotal Phase III trial. A subset analysis of use of blood products indicated that the HBOC-201 group required no more than the packed red blood cell (PRBC) group and was limited to less than 6% in both treatment groups. In a subset analysis from one site, platelet function using PFA-100 was assessed before and after transfusion, and compared those receiving HBOC-201 versus PRBC. After initial IRB approval, patient consent for the Phase III trial and blood draws for PFA-100, an additional IRB exemption for retrospective chart review was obtained. cEPI and cADP means were compared at seven time periods: true baseline(before starting surgery and anesthesia), before transfusion, after transfusion, 1 day, 2 days, 3 to 9 days and 21 or more days after transfusion. Twenty-seven (HBOC: n = 12, PRBC: n = 15) subjects were studied. Comparing data from before transfusion and baseline did not show statistically significant differences in any of cEPI or cADP measurements. cEPI means for the HBOC-201 group increased after transfusion compared to the true baseline (P = 0.01), before transfusion (P = 0.0004) and day 1 after transfusion (P = 0.002). cADP means for the HBOC-201 group were greater after transfusion compared to the true baseline (P = 0.05) and before transfusion (P = 0.005). In the PRBC group there were no significant difference in cEPI and cADP means between all of the time periods. Our study shows that HBOC-201 causes mild platelet dysfunction. Although there were significant changes after HBOC infusion and cEPI and cADP mean values were above the upper normal limit, they did not reach the non-closure time. Further controlled studies are needed to establish definitively the effects that HBOC-201 has on platelet function in patients.
KW - HBOC-201
KW - Hemoglobin-based oxygen carrier
KW - Hemoglobin-glutamer 250 (bovine)
KW - Hemopure
KW - PFA-100
KW - Platelet dysfunction
UR - http://www.scopus.com/inward/record.url?scp=77949942370&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77949942370&partnerID=8YFLogxK
U2 - 10.1097/MJT.0b013e3181a2b08d
DO - 10.1097/MJT.0b013e3181a2b08d
M3 - Article
C2 - 19417588
AN - SCOPUS:77949942370
VL - 17
SP - 140
EP - 147
JO - American Journal of Therapeutics
JF - American Journal of Therapeutics
SN - 1075-2765
IS - 2
ER -