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Thromboelastography-guided blood transfusion during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy: study protocol for a prospective randomised controlled trial
  1. Shaoheng Wang1,
  2. Qing Zhang1,
  3. Linfeng Chen2,
  4. Gang Liu3,
  5. Peng fei Liu1
  1. 1Department of Anesthesiology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China
  2. 2Department of Blood Transfusion, Beijing Shijitan Hospital, Capital Medical University, Beijing, China
  3. 3Department of Peritoneal Cancer Surgery, Beijing Shijitan Hospital, Capital Medical University, Beijing, China
  1. Correspondence to Dr Peng fei Liu; sfflpf{at}126.com

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number Chinese Clinical Trial Registry (ChiCTR2000028835).

  • bleeding disorders & coagulopathies
  • anaesthesia in oncology
  • gastrointestinal tumours
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors SW and QZ contributed equally to this work and should be considered co-first authors. SW and QZ contributed to the conception and drafting of the first manuscript for this trial. PfL is the principal investigator of the entire study and edited the final manuscript. LC and GL contributed to the conception of the research protocol and will participate in the follow-up for this trial. All authors critically revised and modified the protocol and the article. They all approved the final version to be published.

  • Funding This research was supported by The Youth Science Foundation of Beijing Shijitan Hospital Affiliated with Capital Medical University (No. 2019-q19).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Obtained.

  • Provenance and peer review Not commissioned; externally peer-reviewed.

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