Department of Anesthesiology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Department of Blood Transfusion, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
BMJ Open. 2020 Nov 12;10(11):e042741. doi: 10.1136/bmjopen-2020-042741.
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is a well-established treatment for peritoneal cancer (PC). However, this kind of combination therapy is associated with a high incidence of complications. Moreover, relative studies have indicated that traditional laboratory testing is insufficient to demonstrate the overall haemostatic physiology of CRS/HIPEC. Thromboelastography (TEG), administered by monitoring dynamic changes in haemostasis, has been shown to contribute to reducing transfusion requirements and improving survival. However, there is no evidence to verify whether TEG can be applied to guide transfusion strategies during CRS/HIPEC. Therefore, we aim to investigate whether TEG-guided blood product transfusion (TEG-BT) therapy is superior to traditional blood product transfusion (T-BT) therapy for guiding perioperative blood transfusion treatment and improving the prognosis of patients undergoing CRS/HIPEC.
The TEG-BT versus T-BT study is a single-centre, randomised, blinded outcome assessment clinical trial of 162 patients with PC, aged 18-64 years and undergoing CRS/HIPEC. Participants will be randomly allocated to receive TEG-BT or T-BT. The primary outcome will be the evaluation of perioperative blood transfusion, which refers to the total amount of blood transfusion given from the time patients enter the operating room up to 72 hours postoperatively. The secondary outcomes will include the transfusion volume during surgery, total amount of intraoperative infusion, amount of blood lost during the operation, total blood transfusion between 0 and 72 hours after surgery, lowest haemoglobin level within 72 hours after surgery, intensive care unit duration, overall length of stay, total cost of hospitalisation and adverse events. Data will be analysed according to the intention-to-treat principle.
The study protocol has been approved by the Scientific Research Ethics Committee of Beijing Shijitan Hospital Affiliated with Capital Medical University (Approval Number: sjtkyll-lx-2020-3). The results will be published in peer-reviewed journals.
Chinese Clinical Trial Registry (ChiCTR2000028835).
细胞减灭术联合腹腔热灌注化疗（CRS/HIPEC）是一种治疗腹膜癌（PC）的成熟方法。然而，这种联合治疗与较高的并发症发生率相关。此外，相关研究表明，传统的实验室检测不足以证明 CRS/HIPEC 的整体止血生理学。血栓弹力图（TEG）通过监测止血的动态变化来进行管理，已被证明有助于减少输血需求并提高生存率。然而，目前尚无证据证实 TEG 是否可用于指导 CRS/HIPEC 期间的输血策略。因此，我们旨在研究 TEG 指导的血液制品输注（TEG-BT）治疗是否优于传统的血液制品输注（T-BT）治疗，以指导围手术期输血治疗并改善接受 CRS/HIPEC 的患者的预后。
TEG-BT 与 T-BT 研究是一项针对年龄在 18-64 岁之间并接受 CRS/HIPEC 的 162 例 PC 患者的单中心、随机、盲法结局评估临床试验。参与者将被随机分配接受 TEG-BT 或 T-BT。主要结局将是评估围手术期输血，指的是从患者进入手术室到术后 72 小时内给予的总输血量。次要结局将包括手术期间的输血量、术中总输液量、手术期间失血总量、术后 0 至 72 小时内的总输血量、术后 72 小时内的最低血红蛋白水平、重症监护病房持续时间、总住院时间、总住院费用和不良事件。数据将根据意向治疗原则进行分析。
该研究方案已获得首都医科大学附属北京世纪坛医院科学研究伦理委员会的批准（批准号：sjtkyll-lx-2020-3）。研究结果将发表在同行评议的期刊上。
中国临床试验注册中心（ChiCTR2000028835）。
