Fibrinogen and Intraoperative Bleeding in Liver Transplant

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    700
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 25 July 2021
liver disease
liver transplant

Summary

Liver transplantation is the only treatment for end-stage liver disease. It is a high-risk surgery that can cause heavy intraoperative bleeding. Bleeding and transfusions of blood products are themselves associated with several postoperative complications. Few data have suggested beneficial interventions that can decrease this bleeding. Such interventions are necessary in order to improve these patients' outcomes. In order to better understand the potential therapeutic targets, a better comprehension of the variables associated with such bleeding is essential. Several previous studies have demonstrated a weak association between usual clotting times and bleeding in this population. However, few studies have evaluated the association between the concentration of fibrinogen and bleeding in this population.

The primary objective of this study is to assess the association between preoperative serum fibrinogen concentration and the volume of intraoperative bleeding. The secondary objective is to assess the association between preoperative serum fibrinogen concentration and the number of red blood cell units transfused during the intraoperative and immediate postoperative periods.

The hypothesis of the study is that a low concentration of preoperative fibrinogen will be associated with an increase in intraoperative bleeding and red blood cell transfusions.

Description

All patients who received a liver transplant between July 2008 and December 2020 at the Centre Hospitalier de l'Universit de Montral (CHUM) and the hepato-biliary center of the Paul-Brousse Hospital between January 2017 and December 2020 will be included. The effect of fibrinogen concentration, intraoperative bleeding, intraoperative and postoperative transfusions, as well as postoperative bleeding-related complications and mortality up to 1 year will be assessed. The analysis will be adjusted for several confounding factors, including other coagulation parameters. The main association model will be a multivariable linear regression.

This study will be used to further explore the association between fibrinogen concentration and bleeding in liver transplantation. These results may help certain clinical decisions, without suggesting any potential effect of fibrinogen correction on clinical outcomes. If an association is found, the bases will be put in place to build a clinical trial evaluating the effects of a preemptive transfusion of blood products correcting this value on clinical outcomes.

Details
Condition End Stage Liver Disease, Hepatic Failure, chronic liver failure, Liver Transplant; Complications, Liver Transplant; Complications, Liver Transplant; Complications, Liver Transplant; Complications, Liver Transplant; Complications
Clinical Study IdentifierNCT04925843
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients undergoing liver transplant

Exclusion Criteria

Use of cryoprecipitate or fresh frozen plasma after measurement of serum fibrinogen concentration prior to arrival in the operating room
Amyloid neuropathy
Fulminant hepatitis
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