Fibrinogen and Intraoperative Bleeding in Liver Transplant

NCT04925843 | Completed

• 1 other identifier: 19.115
• Study Type: observational
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver DIsease; Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Estimated blood loss per mass of red blood cells lost

  In milliliters

  Up to 48 hours after surgery

Secondary Outcomes (5)

• Number of red blood cell transfusions during liver transplantation

  At the end of surgery

• Number of perioperative red blood cell transfusions

  From the beginning of surgery until 48 hours after surgery

• Occurrence of bleeding complications leading to reintervention and / or angioembolization

  30 days after surgery

• Occurrence of early retransplantation

  30 days after surgery

• One year survival

  One year after surgery

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• Adult patients undergoing liver transplant.

You may not qualify if:

• 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

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, 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.

  PMID: 36150121 RESULT

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• François Martin Carrier, MD, PhD

  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: June 8, 2021
• First Posted: June 14, 2021
• Study Start: July 15, 2019
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CA (1)