Intraoperative Phlebotomies and Bleeding in Liver Transplantation

NCT04826666 | Completed

• 1 other identifier: 20.436
• Study Type: observational
• Target: 679
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery. To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis.

Conditions

Liver Diseases; Liver Cirrhosis; Surgery; Surgery--Complications; Postoperative Complications; Transplant; Failure, Liver

Outcome Measures

Primary Outcomes (1)

• Intraoperative bleeding

  The intervention of interest is aimed at reducing bleeding. Even though intraoperative bleeding measurement is subject to measurement error, such measurement is homogeneously done through a cellsaver device at the CHUM..

  During the liver transplantation

Secondary Outcomes (3)

• Perioperative red blood cell transfusions

  Up to 48 hours after liver transplantation

• Any intraoperative red blood cell transfusions

  During the liver transplantation

• Survival up to 1 year after liver transplantation

  1 year after liver transplantation

Study Arms (1)

Groups/Cohorts

The Principal Investigator propose to conduct a retrospective observational cohort study of all consecutive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).

You may qualify if:

• \- All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).

You may not qualify if:

• \- All patients who were under renal replacement therapy prior to surgery as well as those who had a glomerular filtration rate below 30 mL/h (based on MDRD formula).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (1)

• Carrier FM, Ferreira Guerra S, Coulombe J, Amzallag E, Massicotte L, Chasse M, Trottier H. Intraoperative phlebotomies and bleeding in liver transplantation: a historical cohort study and causal analysis. Can J Anaesth. 2022 Apr;69(4):438-447. doi: 10.1007/s12630-022-02197-1. Epub 2022 Feb 2.

  PMID: 35112303 DERIVED

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François-Martin Carrier, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 31, 2021
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-03

Locations

CA (1)