Efficacy of autologous plateletpheresis in adult aortic surgery: study protocol for a randomised controlled trial.

Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE

Original Publication: [London] : BMJ Publishing Group Ltd, 2011-

Plateletpheresis* ; Blood Transfusion*; Humans ; Adult ; Prospective Studies ; Single-Blind Method ; Cardiopulmonary Bypass ; Randomized Controlled Trials as Topic

Introduction: 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.
Methods and Analysis: 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.
Ethics and Dissemination: 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.
Trial Registration Number: Chinese Clinical Trial Register (ChiCTR2200065834).
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Br J Anaesth. 2012 Jul;109(1):55-68. (PMID: 22628393)
Transfusion. 1995 Aug;35(8):627-34. (PMID: 7631401)
Perfusion. 2015 Nov;30(8):643-9. (PMID: 25713053)
J Card Surg. 2020 Jun;35(6):1220-1227. (PMID: 32353903)
Anesth Analg. 2020 Feb;130(2):e32. (PMID: 31702696)
J Cardiothorac Vasc Anesth. 2020 Mar;34(3):772-781. (PMID: 31416676)
Crit Care. 2007;11(2):R31. (PMID: 17331245)
Ann Thorac Surg. 2013 May;95(5):1525-30. (PMID: 23245451)
Aorta (Stamford). 2014 Aug 01;2(4):129-34. (PMID: 26798730)
Thromb Haemost. 2001 Jun;85(6):958-65. (PMID: 11434702)
Platelets. 2022 Jan 2;33(1):5-13. (PMID: 34392769)
Ann Thorac Surg. 1993 Sep;56(3):433-9; discussion 440. (PMID: 8379713)
Int J Artif Organs. 1987 Jan;10(1):47-50. (PMID: 3570542)
PLoS One. 2021 Oct 28;16(10):e0259116. (PMID: 34710186)
JAMA. 2019 Mar 12;321(10):983-997. (PMID: 30860564)
Anesthesiology. 2021 Mar 1;134(3):471-479. (PMID: 33411916)
Physiol Rev. 2013 Jan;93(1):327-58. (PMID: 23303912)
Anaesthesist. 1977 Feb;26(2):64-71. (PMID: 842811)
J Cardiothorac Vasc Anesth. 2020 Jun;34(6):1614-1621. (PMID: 31420312)
Chin Med Sci J. 2022 Sep 30;37(3):246-260. (PMID: 35172919)
Ann Thorac Surg. 2015 Apr;99(4):1282-90. (PMID: 25661906)
Blood Rev. 2014 Mar;28(2):41-7. (PMID: 24491804)
Anesth Analg. 2005 Jun;100(6):1781-1785. (PMID: 15920213)
Med J Islam Repub Iran. 2017 Jul 10;31:37. (PMID: 29445666)
J Thorac Cardiovasc Surg. 2020 Jun;159(6):2288-2297.e1. (PMID: 31519411)
Platelets. 2022 Oct 3;33(7):987-997. (PMID: 35257629)
Perfusion. 2019 Apr;34(3):236-245. (PMID: 30444188)
J Extra Corpor Technol. 2005 Mar;37(1):9-14. (PMID: 15804151)
Vox Sang. 2010 Jul 1;99(1):1-15. (PMID: 20059760)
Anesthesiology. 2012 Jun;116(6):1367-76. (PMID: 22487863)
Ann Thorac Surg. 2011 Mar;91(3):944-82. (PMID: 21353044)
J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. (PMID: 24332097)
Transfusion. 2004 Oct;44(10):1453-62. (PMID: 15383018)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
Semin Cardiothorac Vasc Anesth. 2014 Jun;18(2):137-45. (PMID: 24876229)
Platelets. 2016 Dec;27(8):751-757. (PMID: 27164510)
Int J Angiol. 2017 Sep;26(3):135-142. (PMID: 28804230)
J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. (PMID: 29029990)
Ann Thorac Surg. 2008 Apr;85(4):1490-5. (PMID: 18355567)

Keywords: Anaesthesia in cardiology; Blood bank & transfusion medicine; Cardiac surgery

ChiCTR ChiCTR2200065834

Date Created: 20230607 Date Completed: 20230609 Latest Revision: 20230623

20231215

PMC10255044

10.1136/bmjopen-2023-073341

37286322