PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: Recruiting start date: July 1, 2019; expected recruiting end date: July 1, 2024 Version number and date: Version 2 of 05-04-2019.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: Recruiting start date: July 1, 2019; expected recruiting end date: July 1, 2024 Version number and date: Version 2 of 05-04-2019.
摘要：
背景：在心脏主动脉手术中，急性等容血液稀释（ANH）和自体富血小板血浆（aPRP）均已被证明具有血液保护作用；然而，两种方法的效果没有比较。本研究旨在比较主动脉手术前aPRP和ANH对术后出血和其他结局的影响。
方法：这是一个前瞻性的，单中心,双盲对照临床试验，包括160例患者，随机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术后24、48和72h的引流量。次要结果包括同种异体血液和血液制品的输入和主动脉传导阻滞的持续时间，体外循环,深低温停止循环，气管拔管,住院,二次手术止血的要求，两组均应用主动脉内球囊反搏或体外膜氧合。此外,心率,收缩压,舒张压,中心静脉压,并在血液保存前记录血栓弹力图（T1），血液保存后（T2），输血前（T3），并在回输血液(T4)后对两组患者进行比较。
结论：这项研究将证明与ANH相比，使用aPRP是否可以降低主动脉手术后出血的风险。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。
背景：本研究已在中国临床试验注册中心注册（http://www.chictr.org.cn/)的ID为ChiCTR1900023351。2019年5月23日注册。
方法：招聘开始日期：2019年7月1日；预计招聘结束日期：2024年7月1日版本号和日期：05-04-2019第2版。
方法：这是一个前瞻性的，单中心,双盲对照临床试验，包括160例患者，随机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术后24、48和72h的引流量。次要结果包括同种异体血液和血液制品的输入和主动脉传导阻滞的持续时间，体外循环,深低温停止循环，气管拔管,住院,二次手术止血的要求，两组均应用主动脉内球囊反搏或体外膜氧合。此外,心率,收缩压,舒张压,中心静脉压,并在血液保存前记录血栓弹力图（T1），血液保存后（T2），输血前（T3），并在回输血液(T4)后对两组患者进行比较。
结论：这项研究将证明与ANH相比，使用aPRP是否可以降低主动脉手术后出血的风险。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。
背景：本研究已在中国临床试验注册中心注册（http://www.chictr.org.cn/)的ID为ChiCTR1900023351。2019年5月23日注册。
方法：招聘开始日期：2019年7月1日；预计招聘结束日期：2024年7月1日版本号和日期：05-04-2019第2版。
