Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial.
Autologous blood transfusion
Blood loss
Blood transfusion
Hemodilution
Hepatectomy
Hypovolemia
Liver resection
Phlebotomy
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
18 Jan 2023
18 Jan 2023
Historique:
received:
22
10
2022
accepted:
12
12
2022
entrez:
18
1
2023
pubmed:
19
1
2023
medline:
21
1
2023
Statut:
epublish
Résumé
Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.
Identifiants
pubmed: 36653812
doi: 10.1186/s13063-022-07008-y
pii: 10.1186/s13063-022-07008-y
pmc: PMC9848035
doi:
Banques de données
ClinicalTrials.gov
['NCT03651154']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
38Informations de copyright
© 2023. The Author(s).
Références
Anesth Analg. 2005 May;100(5):1416-1421
pubmed: 15845698
Transfusion. 2010 Apr;50(4):753-65
pubmed: 20003061
Can J Anaesth. 2021 Feb;68(2):245-255
pubmed: 33236277
Transfusion. 2014 Sep;54(9):2344-52
pubmed: 25100209
Br J Surg. 1998 Aug;85(8):1058-60
pubmed: 9717995
Nan Fang Yi Ke Da Xue Xue Bao. 2006 Jun;26(6):828-30
pubmed: 16793612
Transplantation. 2012 Jun 27;93(12):1276-81
pubmed: 22617090
Br J Surg. 1996 Nov;83(11):1526-9
pubmed: 9014666
Transfusion. 2018 Mar;58(3):781-787
pubmed: 29322515
Br J Surg. 2017 Mar;104(4):434-442
pubmed: 28079259
Clin Liver Dis. 2009 Feb;13(1):145-154
pubmed: 19150318
Liver Cancer. 2013 Jan;2(1):55-66
pubmed: 24159597
JAMA. 2019 Mar 12;321(10):983-997
pubmed: 30860564
Lancet. 2005 Feb 19-25;365(9460):711-22
pubmed: 15721478
Ann Surg. 2022 Jul 21;:
pubmed: 35861339
Cochrane Database Syst Rev. 2016 Oct 31;10:CD010683
pubmed: 27797116
World J Gastroenterol. 2006 Feb 14;12(6):935-9
pubmed: 16521223
HPB (Oxford). 2019 Jun;21(6):757-764
pubmed: 30501988
Eur J Anaesthesiol Suppl. 1997 Mar;14:35-7
pubmed: 9088833
J Surg Oncol. 2014 Feb;109(2):81-8
pubmed: 24449171
Control Clin Trials. 1981 Jun;2(2):93-113
pubmed: 7273794
Cochrane Database Syst Rev. 2012 May 16;(5):CD007338
pubmed: 22592720
HPB (Oxford). 2015 Oct;17(10):863-71
pubmed: 26292655
J Surg Oncol. 2014 Dec;110(8):947-51
pubmed: 25154605
Br J Surg. 2020 Jun;107(7):812-823
pubmed: 31965573
Ann Surg Oncol. 2015 Nov;22(12):4038-45
pubmed: 25752895
J Surg Res. 2015 Jun 15;196(2):221-8
pubmed: 25881789
Ann Surg. 2013 Jul;258(1):1-7
pubmed: 23728278
Ann Surg. 2004 Oct;240(4):698-708; discussion 708-10
pubmed: 15383797
JAMA. 2016 Nov 15;316(19):2025-2035
pubmed: 27732721
Ann Surg. 2009 Dec;250(6):914-21
pubmed: 19953711
Liver Transpl. 2006 Jan;12(1):117-23
pubmed: 16382461
Can J Anaesth. 2014 Nov;61(11):1059-60
pubmed: 25091297
Transfusion. 2004 Oct;44(10):1479-86
pubmed: 15383022
HPB (Oxford). 2020 Mar;22(3):340-350
pubmed: 31734240
Ann Surg Oncol. 2017 May;24(5):1367-1375
pubmed: 28054191
Ann Surg. 2018 Apr;267(4):766-774
pubmed: 28288056
Crit Care. 2004 Oct;8(5):373-81
pubmed: 15469601
Ann Surg. 2013 Jun;257(6):1079-88
pubmed: 23426338
Lancet. 2005 May 7-13;365(9471):1657-61
pubmed: 15885299
Ann Surg. 2008 Sep;248(3):360-9
pubmed: 18791356
Langenbecks Arch Surg. 2019 Feb;404(1):1-9
pubmed: 30607533
Ann Surg. 2004 Aug;240(2):205-13
pubmed: 15273542
Clin Chem. 1974 May;20(5):615-6
pubmed: 4826961
Cochrane Database Syst Rev. 2009 Oct 07;(4):CD008085
pubmed: 19821442
HPB (Oxford). 2017 Apr;19(4):321-330
pubmed: 28161216
Ann Surg. 2016 Jul;264(1):41-6
pubmed: 26817624
Surgery. 2017 Mar;161(3):650-657
pubmed: 27712877
Can J Surg. 2009 Dec;52(6):E264-8
pubmed: 20011162
World J Gastroenterol. 2014 Jan 7;20(1):303-9
pubmed: 24415886
Anesthesiology. 2008 Apr;108(4):735-48
pubmed: 18362606
BMJ. 2000 Sep 16;321(7262):694-6
pubmed: 10987780
Br J Anaesth. 2005 Jul;95(1):33-42
pubmed: 15486006
BMJ. 2010 Mar 30;340:c117
pubmed: 20354011
Br J Surg. 1998 Feb;85(2):188-90
pubmed: 9501812
Transplantation. 2010 Apr 27;89(8):920-7
pubmed: 20216483
Can J Anaesth. 2022 Apr;69(4):438-447
pubmed: 35112303
Can J Anaesth. 2021 Jul;68(7):980-990
pubmed: 33945107
Arch Surg. 1994 Oct;129(10):1050-6
pubmed: 7944934
Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7
pubmed: 12368667
Ann Surg. 2007 May;245(5):686-91
pubmed: 17457160
Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005033
pubmed: 16437512
HPB (Oxford). 2012 Apr;14(4):236-41
pubmed: 22404261