Fibrinogen and Intraoperative Bleeding in Liver Transplant (FIB_TOF)

Association Between Fibrinogen Concentration and Intraoperative Bleeding in Liver Transplantation: a Retrospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications; End Stage Liver DIsease

Detailed Description

All patients who received a liver transplant between July 2008 and January 2021 at the Centre Hospitalier de l'Université de Montréal (CHUM) 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.

• Study Type: Observational
• Enrollment (Actual): 612

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Centre hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent a liver transplant for a chronic liver disease during the reference period.

Description

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 or liver cancer
• Fulminant hepatitis
• Retransplantation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing liver transplant for end-stage liver disease; The investigators propose to conduct a retrospective cohort study to explore the association between fibrinogen concentration and intraoperative bleeding in patients who underwent a liver transplant between July 2008 and January 2021.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss per mass of red blood cells lost	In milliliters	Up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of red blood cell transfusions during liver transplantation	Count	At the end of surgery
Number of perioperative red blood cell transfusions	Count	From the beginning of surgery until 48 hours after surgery
Occurrence of bleeding complications leading to reintervention and / or angioembolization	Dichotomous	30 days after surgery
Occurrence of early retransplantation	Dichotomous	30 days after surgery
One year survival	Time to event	One year after surgery

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Carrier FM, Deshetres A, Ferreira Guerra S, Rioux-Masse B, Zaouter C, Lee N, Amzallag E, Joosten A, Massicotte L, Chasse M. Preoperative Fibrinogen Level and Bleeding in Liver Transplantation for End-stage Liver Disease: A Cohort Study. Transplantation. 2022 Sep 23. doi: 10.1097/TP.0000000000004333. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Hemorrhage; Intraoperative Complications; Liver Diseases; End Stage Liver Disease; Blood Loss, Surgical
• Other Study ID Numbers: 19.115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No