Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: Results of a randomized, double-blind trial
Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: Results of a randomized, double-blind trial
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DOI：
10.1067/mtc.2002.121505
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发表时间：
2002-07-01
影响因子：
6
通讯作者：
Vlahakes, GJ
中科院分区：
文献类型：
--
作者：
Levy, JH;Goodnough, LT;Vlahakes, GJ
背景：导致携氧能力降低的失血通常通过输注红细胞来治疗。本研究检验了血红蛋白为基础的携氧溶液可以作为红细胞输血的初始替代方案的假设。方法：在HBOC-201的随机双盲疗效试验中，共有98例接受心脏手术并需要输血的患者被随机分配接受红细胞单位或HBOC-201（Hemopure; Biopure Corporation，剑桥，Mass）进行前三次术后输血。患者在输血前和输血后，出院时，并在3至4周后，随后的红细胞使用，血流动力学，和临床实验室parameters.Results：使用HBOC-201消除了红细胞输血的需要在34%的情况下（95%的置信区间21%-49%）。HBOC组患者平均接受1.72个后续单位的红细胞;接受红细胞的患者平均仅接受2.19个后续单位（P = .05）。HBOC组的红细胞压积值短暂降低，但出院和随访时两组相似。HBOC组的氧提取率更高（P = .05）。平均增加的血压更大的HBOC组，但不显着。结论：HBOC-201可能是一个初步的替代红细胞输注中度贫血患者心脏手术后。在三分之一的病例中，HBOC-201消除了对红细胞输注的需要，尽管需要大量剂量才能产生这种适度的血液保护。
Background: Blood loss leading to reduced oxygen-carrying capacity is usually treated with red blood cell transfusions. This study examined the hypothesis that a hemoglobin-based oxygen-carrying solution can serve as an initial alternative to red blood cell transfusion.Methods: In a randomized, double-blind efficacy trial of HBOC-201, a total of 98 patients undergoing cardiac surgery and requiring transfusion were randomly assigned to receive either red blood cell units or HBOC-201 (Hemopure; Biopure Corporation, Cambridge, Mass) for the first three postoperative transfusions. Patients were monitored before and after transfusion, at discharge, and at 3 to 4 weeks after the operation for subsequent red blood cell use, hemodynamics, and clinical laboratory parameters.Results: The use of HBOC-201 eliminated the need for red blood cell transfusions in 34% of cases (95% confidence interval 21%-49%). Patients in the HBOC group received a mean of 1.72 subsequent units of red blood cells; those who received red blood cells only received a mean of 2.19 subsequent units (P = .05). Hematocrit values were transiently lower in the HBOC group but were similar in the two groups at discharge and follow-up. Oxygen extraction was greater in the HBOC group (P = .05). Mean increases in blood pressure were greater in the HBOC group, but not significantly so.Conclusion: HBOC-201 may be an initial alternative to red blood cell transfusions for patients with moderate anemia after cardiac surgery. In a third of cases, HBOC-201 eliminated the need for red blood cell transfusion, although substantial doses were needed to produce this modest degree of blood conservation.