The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution

Glenn M. LaMuraglia, Patrick J. O'Hara, William H. Baker, Thomas C. Naslund, Edward J. Norris, Jolly Li, Eugene Vandermeersch

Research output: Contribution to journalArticle

Abstract

Objective: Because of allogenic red blood cell (RBC) availability and infection problems, novel alternatives, including hemoglobin-based oxygen- carrying solutions (HBOC), are being explored to minimize the perioperative requirement of RBC transfusions. This study evaluated HBOC-201, a room- temperature stable, polymerized, bovine-HBOC, as a substitute for allogenic RBC transfusion in patients undergoing elective infrarenal aortic operations. Methods: In a single blind, multicenter trial, 72 patients were prospectively randomized two-to-one to HBOC (n = 48) or allogenic RBC (n = 24) at the time of the first transfusion decision, either during or after elective infrarenal aortic reconstruction. Patients randomized to the HBOC group received 60 g of HBOC for the initial transfusion and had the option to receive three more doses (30 g each) within 96 hours. In this group, any further blood requirement was met with allogenic RBCs. Patients randomized to the allogenic RBC group received only standard RBC transfusions. The efficacy analysis was a means of assessing the ability of HBOC to eliminate the requirement for any allogenic RBC transfusions from the time of randomization through 28 days. Safety was evaluated by means of standard clinical trial methods. Results: The two treatment groups were comparable for all baseline characteristics. Although all patients in the allogenic RBC group required at least one allogenic RBC transfusion, 13 of 48 patients (27%; 95% CI, 15% to 42%) in the HBOC group did not require any allogenic RBC transfusions. The only significant changes documented were a 15% increase in mean arterial pressure and a three-fold peak increase in serum urea nitrogen concentration after HBOC. The complications were similar in both groups, with no allergic reactions. There were two perioperative deaths (8%) in the allogenic RBC group and three perioperative deaths (6%) in the HBOC group (P = 1.0). Conclusion: HBOC significantly eliminated the need for any allogenic RBC transfusion in 27% of patients undergoing infrarenal aortic reconstruction, but did not reduce the median allogenic RBC requirement. HBOC transfusion was well tolerated and did not influence morbidity or mortality rates.

Original languageEnglish (US)
Pages (from-to)299-308
Number of pages10
JournalJournal of Vascular Surgery
Volume31
Issue number2
StatePublished - 2000

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Hemoglobins
Erythrocyte Transfusion
Oxygen
Erythrocytes
Blood Group Antigens
Random Allocation
Multicenter Studies
Urea
Arterial Pressure
Hypersensitivity
Nitrogen
Clinical Trials
Morbidity
Safety
Temperature
Mortality
Infection
Serum

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

LaMuraglia, G. M., O'Hara, P. J., Baker, W. H., Naslund, T. C., Norris, E. J., Li, J., & Vandermeersch, E. (2000). The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution. Journal of Vascular Surgery, 31(2), 299-308.

The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution. / LaMuraglia, Glenn M.; O'Hara, Patrick J.; Baker, William H.; Naslund, Thomas C.; Norris, Edward J.; Li, Jolly; Vandermeersch, Eugene.

In: Journal of Vascular Surgery, Vol. 31, No. 2, 2000, p. 299-308.

Research output: Contribution to journalArticle

LaMuraglia, GM, O'Hara, PJ, Baker, WH, Naslund, TC, Norris, EJ, Li, J & Vandermeersch, E 2000, 'The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution', Journal of Vascular Surgery, vol. 31, no. 2, pp. 299-308.
LaMuraglia GM, O'Hara PJ, Baker WH, Naslund TC, Norris EJ, Li J et al. The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution. Journal of Vascular Surgery. 2000;31(2):299-308.
LaMuraglia, Glenn M. ; O'Hara, Patrick J. ; Baker, William H. ; Naslund, Thomas C. ; Norris, Edward J. ; Li, Jolly ; Vandermeersch, Eugene. / The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution. In: Journal of Vascular Surgery. 2000 ; Vol. 31, No. 2. pp. 299-308.
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abstract = "Objective: Because of allogenic red blood cell (RBC) availability and infection problems, novel alternatives, including hemoglobin-based oxygen- carrying solutions (HBOC), are being explored to minimize the perioperative requirement of RBC transfusions. This study evaluated HBOC-201, a room- temperature stable, polymerized, bovine-HBOC, as a substitute for allogenic RBC transfusion in patients undergoing elective infrarenal aortic operations. Methods: In a single blind, multicenter trial, 72 patients were prospectively randomized two-to-one to HBOC (n = 48) or allogenic RBC (n = 24) at the time of the first transfusion decision, either during or after elective infrarenal aortic reconstruction. Patients randomized to the HBOC group received 60 g of HBOC for the initial transfusion and had the option to receive three more doses (30 g each) within 96 hours. In this group, any further blood requirement was met with allogenic RBCs. Patients randomized to the allogenic RBC group received only standard RBC transfusions. The efficacy analysis was a means of assessing the ability of HBOC to eliminate the requirement for any allogenic RBC transfusions from the time of randomization through 28 days. Safety was evaluated by means of standard clinical trial methods. Results: The two treatment groups were comparable for all baseline characteristics. Although all patients in the allogenic RBC group required at least one allogenic RBC transfusion, 13 of 48 patients (27{\%}; 95{\%} CI, 15{\%} to 42{\%}) in the HBOC group did not require any allogenic RBC transfusions. The only significant changes documented were a 15{\%} increase in mean arterial pressure and a three-fold peak increase in serum urea nitrogen concentration after HBOC. The complications were similar in both groups, with no allergic reactions. There were two perioperative deaths (8{\%}) in the allogenic RBC group and three perioperative deaths (6{\%}) in the HBOC group (P = 1.0). Conclusion: HBOC significantly eliminated the need for any allogenic RBC transfusion in 27{\%} of patients undergoing infrarenal aortic reconstruction, but did not reduce the median allogenic RBC requirement. HBOC transfusion was well tolerated and did not influence morbidity or mortality rates.",
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