Lambert W, Brisebois F J, Wharton T J, Carrier R C, Boyle D, Rowe B H
Sudbury Memorial Hospital, Department of Anesthesiology, University of Alberta, Edmonton, Alberta.
Can J Anaesth. 1998 Jun;45(6):571-4. doi: 10.1007/BF03012711.
This randomized controlled clinical trial compared three doses of tranexamic acid (TA) in primary cardiac surgery in terms of blood loss and transfusion requirements.
Patients presenting for primary coronary artery bypass grafting (CABG) and/or valve replacement were randomly assigned to one of three TA regimens: 20 mg.kg-1 (LD), 50 mg.kg-1 (MD), and 100 mg.kg-1 (HD). All participants and staff were blinded to the allocation. Haemoglobin (Hgb), haematocrit and platelet count were determined preoperatively, after bypass, at CCA arrival, and 12 and 24 hr after surgery. Coagulation parameters were measured before and after surgery. Blood loss was measured intraoperatively and for 24 hr postoperatively following a standardized protocol. Blood products were administered in a standardized fashion.
Two hundred twenty patients completed the trial over 10 months: 74 in LD, 75 in MD and 72 in HD dose groups. All patients groups were comparable; similar procedures were performed in each group. No differences were identified for blood loss intra-operatively (490 +/- 232 ml, 523 +/- 413 ml, 488 +/- 357 ml, respectively), 24 hr post-operatively (543 +/- 223 ml, 544 +/- 231, 458 +/- 210 ml, respectively), and overall (1032 +/- 358 ml, 1067 +/- 502 ml, 946 +/- 459 ml, respectively). Blood product administration was similar in the three groups. No differences in postoperative complications were found.
This study demonstrates the equivalency of the three doses of TA in primary cardiac surgical procedures. The use of low dose (20 mg.kg-1) TA results in comparable outcomes, without additional complications.
本随机对照临床试验比较了三种剂量的氨甲环酸(TA)在心脏直视手术中的失血情况和输血需求。
接受初次冠状动脉旁路移植术(CABG)和/或瓣膜置换术的患者被随机分配至三种TA方案之一:20mg·kg-1(低剂量组)、50mg·kg-1(中剂量组)和100mg·kg-1(高剂量组)。所有参与者和工作人员均对分组情况不知情。术前、体外循环后、到达重症监护病房时以及术后12小时和24小时测定血红蛋白(Hgb)、血细胞比容和血小板计数。手术前后测量凝血参数。术中及术后24小时按照标准化方案测量失血量。以标准化方式输注血液制品。
220例患者在10个月内完成试验:低剂量组74例,中剂量组75例,高剂量组72例。所有患者组具有可比性;每组进行的手术相似。术中失血量(分别为490±232ml、523±413ml、488±357ml)、术后24小时失血量(分别为543±223ml、544±231ml、458±210ml)及总失血量(分别为1032±358ml、1067±502ml、946±459ml)均未发现差异。三组血液制品的输注情况相似。术后并发症无差异。
本研究表明三种剂量的TA在心脏直视手术中疗效相当。使用低剂量(20mg·kg-1)TA可获得相似结果,且无额外并发症。