双阿司匹林交联血红蛋白减少非心脏手术中的输血：一项多中心、随机、对照、双盲试验。

Diaspirin-crosslinked hemoglobin reduces blood transfusion in noncardiac surgery: a multicenter, randomized, controlled, double-blinded trial.

作者信息

Schubert Armin, Przybelski Robert J, Eidt John F, Lasky Larry C, Marks Kenneth E, Karafa Matthew, Novick Andrew C, O'Hara Jerome F, Saunders Michael E, Blue John W, Tetzlaff John E, Mascha Edward

机构信息

Departments of *General Anesthesiology, †Department of Orthopedic Surgery, ‡Department of Urology, §Department of Biostatistics & Epidemiology, The Cleveland Clinic Foundation; ∥Cleveland Clinic Foundation Health Science Center of the Ohio State University; ¶Department of Pathology, Ohio State University, Cleveland; #Department of Medicine, University of Wisconsin, Madison; **Division of Vascular Surgery, University of Arkansas for Medical Sciences, Little Rock; ††Baxter Hemoglobin Therapeutics, Boulder, Colorado; ‡‡Pfizer Global Research and Development, New York City; and §§Richard Prielipp, MD, Bowman Gray School of Medicine; Gerald Fulda, MD, Christiana Health Care Services; Irwin Gratz, DO, Cooper Hospital/UMC; Michael Salem, MD, George Washington University Medical Center; Ronald Kline, MD, Harper Hospital; Benjamin Guslits, MD, Henry Ford Hospital; Michael Pasquale, MD, Lehigh Valley Hospital; Lauraine Stewart, MD, McGuire VA Medical Center; Larry Hollier, MD, Mt. Sinai Medical Center; Bhatar Desai, MD, St. Anthony Hospital; Marc J. Shapiro, MD, St. Louis University Hospital; Ronald Pearl, MD, Stanford University Medical Center; Michael J. Williams, MD, Thomas Jefferson University; Dennis Doblar, PhD, MD, University of Alabama-Birmingham; Marc Hudson, MD, University of Pittsburgh Medical Center; Michael P. Eaton, MD, University of Rochester Medical Center; Lewis Gottschalk, MB, University of Texas-Houston Health Sciences Center; Mali Mathru, MD, University of Texas Medical Branch; Daniel Herr, MD, Washington Hospital Center.

出版信息

Anesth Analg. 2003 Aug;97(2):323-332. doi: 10.1213/01.ANE.0000068888.02977.DA.

DOI:10.1213/01.ANE.0000068888.02977.DA

PMID:12873912

Abstract

UNLABELLED

In this randomized, prospective, double-blinded clinical trial, we sought to investigate whether diaspirin-crosslinked hemoglobin (DCLHb) can reduce the perioperative use of allogeneic blood transfusion. One-hundred-eighty-one elective surgical patients were enrolled at 19 clinical sites from 1996 to 1998. Selection criteria included anticipated transfusion of 2-4 blood units, aortic repair, and major joint or abdomino-pelvic surgery. Once a decision to transfuse had been made, patients received initially up to 3 250-mL infusions of 10% DCLHb (n = 92) or 3 U of packed red blood cells (PRBCs) (n = 89). DCLHb was infused during a 36-h perioperative window. On the day of surgery, 58 of 92 (64%; confidence interval [CI], 54%-74%) DCLHb-treated patients received no allogeneic PRBC transfusions. On Day 1, this number was 44 of 92 (48%; CI, 37%-58%) and decreased further until Day 7, when it was 21 of 92 (23%; CI, 15%-33%). During the 7-day period, 2 (1-4) units of PRBC per patient were used in the DCLHb group compared with 3 (2-4) units in the control patients (P = 0.002; medians and 25th and 75th percentiles). Mortality (4% and 3%, respectively) and incidence of suffering at least one serious adverse event (21% and 15%, respectively) were similar in DCLHb and PRBC groups. The incidence of jaundice, urinary side effects, and pancreatitis were more frequent in DCLHb patients. The study was terminated early because of safety concerns. Whereas the side-effect profile of modified hemoglobin solutions needs to be improved, our data show that hemoglobin solutions can be effective at reducing exposure to allogeneic blood for elective surgery.

IMPLICATIONS

In a randomized, double-blinded red blood cell controlled, multicenter trial, diaspirin-crosslinked hemoglobin spared allogeneic transfusion in 23% of patients undergoing elective noncardiac surgery. The observed side-effect profile indicates a need for improvement in hemoglobin development.

摘要

未加标注

在这项随机、前瞻性、双盲临床试验中，我们试图研究双阿司匹林交联血红蛋白（DCLHb）是否能减少围手术期异体输血的使用。1996年至1998年期间，19个临床地点招募了181例择期手术患者。入选标准包括预计输注2 - 4个单位血液、主动脉修复以及大关节或腹部盆腔手术。一旦做出输血决定，患者最初接受最多3次250毫升的10% DCLHb输注（n = 92）或3单位浓缩红细胞（PRBCs）（n = 89）。DCLHb在围手术期36小时内输注。手术当天，92例接受DCLHb治疗的患者中有58例（64%；置信区间[CI]，54% - 74%）未接受异体PRBC输血。在第1天，这一数字为92例中的44例（48%；CI，37% - 58%），并进一步下降直至第7天，此时为92例中的21例（23%；CI，15% - 33%）。在7天期间，DCLHb组患者每人使用2（1 - 4）单位PRBC，而对照组患者为3（2 - 4）单位（P = 0.002；中位数以及第25和第75百分位数）。DCLHb组和PRBC组的死亡率（分别为4%和3%）以及至少发生一次严重不良事件的发生率（分别为21%和15%）相似。DCLHb治疗的患者黄疸、泌尿系统副作用和胰腺炎的发生率更高。由于安全问题，该研究提前终止。虽然改良血红蛋白溶液的副作用情况需要改善，但我们的数据表明血红蛋白溶液在减少择期手术中异体血暴露方面可能有效。