Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
Department of Transfusion Medicine, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
BMJ Open. 2023 Jun 7;13(6):e073341. doi: 10.1136/bmjopen-2023-073341.
Perioperative coagulopathy is common in patients undergoing aortic surgery, increasing the risk of excessive blood loss and subsequent allogeneic transfusion. Blood conservation has become a vital part of cardiovascular surgery, but measures to protect platelets from destruction by cardiopulmonary bypass (CPB) are still lacking. Autologous platelet concentrate (APC) may have potential benefits for intraoperative blood preservation, but its efficacy has not been studied extensively. This study aims to evaluate the efficacy of APC as a blood conservation technique to reduce blood transfusion in adult aortic surgery.
This is a prospective, single-centre, single-blind randomised controlled trial. A total of 344 adult patients undergoing aortic surgery with CPB will be enrolled and randomised to either the APC group or the control group with a 1:1 randomisation ratio. Patients in the APC group will receive autologous plateletpheresis before heparinisation, while those in the control group will not. The primary outcome is the perioperative packed red blood cell (pRBC) transfusion rate. Secondary endpoints include the volume of perioperative pRBC transfusion; drainage volume within 72 hours post-surgery; postoperative coagulation and platelet function; and the incidence of adverse events. Data will be analysed according to the intention-to-treat principle.
This study was approved by the institutional review board of Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (no. 2022-1806). All procedures included in this study will be performed in adherence to the Helsinki Declaration. The results of the trial will be published in an international peer-reviewed journal.
Chinese Clinical Trial Register (ChiCTR2200065834).
围术期凝血功能障碍在接受主动脉手术的患者中较为常见，增加了大量失血和随后异体输血的风险。血液保护已成为心血管手术的重要组成部分，但保护血小板免受体外循环（CPB）破坏的措施仍有待完善。自体血小板浓缩物（APC）可能对术中血液保存具有潜在益处，但尚未广泛研究其疗效。本研究旨在评估 APC 作为一种血液保护技术在成人主动脉手术中减少输血的效果。
这是一项前瞻性、单中心、单盲随机对照试验。共纳入 344 例接受 CPB 主动脉手术的成年患者，按 1:1 比例随机分为 APC 组和对照组。APC 组患者在肝素化前进行自体血小板采集，对照组患者则不进行。主要结局是围术期浓缩红细胞（pRBC）输注率。次要结局包括围术期 pRBC 输注量；术后 72 小时内引流量；术后凝血和血小板功能；以及不良事件发生率。数据将根据意向治疗原则进行分析。
本研究已获得中国医学科学院阜外医院和北京协和医学院伦理委员会批准（编号：2022-1806）。本研究中包含的所有程序均将遵循赫尔辛基宣言进行。试验结果将发表在国际同行评议期刊上。
中国临床试验注册中心（ChiCTR2200065834）。
