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NCT Number: NCT04925843

Fibrinogen and Intraoperative Bleeding in Liver Transplant

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.

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Key information

Conditions

End Stage Liver Disease Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Liver Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Estimated blood loss per mass of red blood cells lost

    Time frame: Up to 48 hours after surgery

    In milliliters

Secondary outcomes

  1. Number of red blood cell transfusions during liver transplantation

    Time frame: At the end of surgery

    Count

  2. Number of perioperative red blood cell transfusions

    Time frame: From the beginning of surgery until 48 hours after surgery

    Count

  3. Occurrence of bleeding complications leading to reintervention and / or angioembolization

    Time frame: 30 days after surgery

    Dichotomous

  4. Occurrence of early retransplantation

    Time frame: 30 days after surgery

    Dichotomous

  5. One year survival

    Time frame: One year after surgery

    Time to event

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: FIB_TOF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2021
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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