Perflubron emulsion delays blood transfusions in orthopedic surgery

被引:121
作者
Spahn, DR [1 ]
van Brempt, R
Theilmeier, G
Reibold, JP
Welte, M
Heinzerling, H
Birck, KM
Keipert, PE
Messmer, K
机构
[1] Univ Zurich Hosp, Inst Anasthesiol, Dept Anesthesiol, CH-8091 Zurich, Switzerland
[2] Univ Hosp Leuven, Dept Anesthesiol, Louvain, Belgium
[3] Univ Hosp Munster, Dept Anesthesiol, Munster, Germany
[4] Univ Hosp Giessen, Dept Anesthesiol, Giessen, Germany
[5] Univ Hosp Munich, Dept Anesthesiol, Munich, Germany
[6] RW Johnson Pharmaceut Res Inst, Clin Res, Zurich, Switzerland
[7] Alliance Pharmaceut Corp, Oxygen Carriers Dev, San Diego, CA 92121 USA
[8] Univ Munich, Inst Surg Res, D-8000 Munich, Germany
关键词
artificial oxygen carrier; blood substitute; hemodilution; oxygent; perfluorocarbon;
D O I
10.1097/00000542-199911000-00009
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
Background: Fluorocarbon emulsions have been proposed as temporary artificial oxygen carriers. The aim of the present study is to compare the effectiveness of perflubron emulsion with the effectiveness of autologous blood or colloid infusion for reversal of physiologic transfusion triggers. Methods: A multinational, multicenter, randomized, controlled, single-blind, parallel group study was performed in 147 orthopedic patients. Patients underwent acute normovolemic hemodilution with colloid to a target hemoglobin of 9 g/dl with an inspiratory oxygen fraction (FIO2) of 0.40. Patients were then randomized into one of four treatment groups after having reached any of the protocol-defined transfusion triggers including tachycardia (heart rate > 125% of posthemodilution rate or > 110 bpm), hypotension (mean arterial pressure < 75% of posthemodilution level or less than or equal to 60 mmHg), elevated cardiac output (> 150% of posthemodilution level) or decreased mixed venous oxygen partial pressure (PVO2; < 38 mmHg). Treatments in the four groups were 450 ml autologous blood harvested during acute normovolemic hemodilution given at FIO2 = 0.40; 450 ml colloid at FIO2 = 1.0; 0.9 g/kg perflubron emulsion with colloid (total = 450 ml) at FIO2 = 1.0; and 1.8 g/kg perflubron emulsion with colloid (total = 450 m) at FIO2 = 1.0. The primary endpoint was duration of transfusion-trigger reversal A secondary endpoint was percentage of transfusion-trigger reversal. Results: Perflubron emulsion was well tolerated with no serious adverse event attributed to drug treatment. Duration of reversal was longest in the 1.8 g/kg perflubron group (median, 80 min; 95% confidence interval, 60-100 min; P = 0.014 vs. autologous blood, P < 0.001 vs. colloid) followed by the 0.9 g/kg perflubron group (median, 59 min; 95% confidence interval, 40-90 min), the autologous blood group (median, 55 min; 95% confidence interval, 30-70 min) and the colloid group (median, 30 min; 95% confidence interval, 27-60 min). Percentage of reversal was also highest in the 1.8 g/kg perflubron group (97%; P < 0.001 us. autologous blood; P = 0.014 vs. colloid), followed by 0.9 g/kg perflubron (82%), colloid (76%), and autologous blood (60%). Conclusions Perflubron emulsion (1.8 g/kg) combined with 100% oxygen ventilation is more effective than autologous blood or colloid infusion in reversing physiologic transfusion triggers.
引用
收藏
页码:1195 / 1208
页数:14
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