Department of Anesthesiology, The First Hospital of China Medical University, 155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province, China.
Trials. 2023 Nov 18;24(1):741. doi: 10.1186/s13063-023-07800-4.
Both acute normovolumic hemodilution (ANH) and autologous platelet-rich plasma (aPRP) have been demonstrated blood-protective effects in cardiac aortic surgery; however, the efficacies of the two methods have not been compared. This study aims to compare the effects of aPRP and ANH prior to aortic surgery on postoperative bleed and other outcomes.
This is a prospective, single-center, double-blind controlled clinical trial including 160 patients randomized 1:1 to receive aPRP (test group) or autologous whole blood (ANH, control group). The primary objective is to compare the drainage volumes in the two groups at 24, 48, and 72 h postoperatively. Secondary outcomes include input of allogeneic blood and blood products and durations of aortic block, extracorporeal circulation, deep hypothermic arrest of circulation, tracheal extubation, hospital stay, requirement for secondary surgical hemostasis, and application of intra-aortic balloon pump or extracorporeal membrane oxygenation in the two groups. In addition, heart rate, systolic blood pressure, diastolic blood pressure, central venous pressure, and thromboelastography recorded before blood reservation (T1), after blood reservation (T2), before blood transfusion (T3), and after the blood is returned (T4) to the transfusion will be compared between the two groups of patients.
This study will demonstrate if the use of aPRP could reduce the risk of bleeding after aortic surgery compared with ANH. The results are expected to have practical clinical applications in terms of more effective blood protection and shorter hospital stay.
This study was registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ) with the ID ChiCTR 1900023351.Registered on May 23, 2019.
Recruiting start date: July 1, 2019; expected recruiting end date: July 1, 2024 Version number and date: Version 2 of 05-04-2019.
急性等容血液稀释（ANH）和自体富血小板血浆（aPRP）均已被证明在心脏主动脉手术中有血液保护作用；然而，这两种方法的疗效尚未进行比较。本研究旨在比较主动脉手术前使用 aPRP 和 ANH 对术后出血和其他结果的影响。
这是一项前瞻性、单中心、双盲对照临床试验，纳入 160 例患者，随机分为 1:1 接受 aPRP（试验组）或自体全血（ANH，对照组）。主要目的是比较两组患者术后 24、48 和 72 小时的引流量。次要结局包括异体输血和血液制品的输入以及主动脉阻断、体外循环、深低温停循环、气管拔管、住院时间、二次手术止血的需求、主动脉内球囊泵或体外膜肺氧合的应用。此外，还比较了两组患者在血液储备前（T1）、血液储备后（T2）、输血前（T3）和输血后（T4）记录的心率、收缩压、舒张压、中心静脉压和血栓弹力图。
本研究将证明与 ANH 相比，使用 aPRP 是否可以降低主动脉手术后出血的风险。研究结果有望在更有效的血液保护和更短的住院时间方面具有实际的临床应用价值。
本研究在中国临床试验注册中心（http://www.chictr.org.cn/）注册，注册号 ChiCTR1900023351。注册日期：2019 年 5 月 23 日。
招募开始日期：2019 年 7 月 1 日；预计招募结束日期：2024 年 7 月 1 日。版本号和日期：2019 年 5 月 4 日的版本 2。
