Fibrinogen and Intraoperative Bleeding in Liver Transplant

NCT ID: NCT04925843

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 612 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2022-01-10

Brief 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.

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.

Conditions

End Stage Liver DIsease; Liver Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Martin Carrier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

References

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. 2023 Mar 1;107(3):693-702. doi: 10.1097/TP.0000000000004333. Epub 2022 Sep 23.

Reference Type: RESULT

PMID: 36150121 (View on PubMed)

Other Identifiers

19.115

Identifier Type: -

Identifier Source: org_study_id