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Fibrinogen and Intraoperative Bleeding in Liver Transplant (FIB_TOF)

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ClinicalTrials.gov Identifier: NCT04925843
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
Hopital Paul Brousse
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease
End Stage Liver DIsease Liver Transplant; Complications

Detailed Description:

All patients who received a liver transplant between July 2008 and December 2020 at the Centre Hospitalier de l'Université de Montréal (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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Fibrinogen Concentration and Intraoperative Bleeding in Liver Transplantation: a Retrospective Observational Study
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

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 December 2020.



Primary Outcome Measures :
  1. Estimated blood loss per mass of red blood cells lost [ Time Frame: 48 hours after surgery ]
    In milliliters


Secondary Outcome Measures :
  1. Number of red blood cell transfusions during liver transplantation [ Time Frame: At the end of surgery ]
  2. Number of perioperative red blood cell transfusions [ Time Frame: From the beginning of surgery until 48 hours after surgery ]
  3. Occurrence of bleeding complications leading to reintervention and / or angioembolization [ Time Frame: 30 days after surgery ]
  4. Occurrence of early retransplantation [ Time Frame: 30 days after surgery ]
  5. One year survival [ Time Frame: One year after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent a liver transplant for a chronic liver disease during the reference period.
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.
  • Fulminant hepatitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925843


Contacts
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Contact: François Martin Carrier, MD, MSc 514-890-8000 ext 12132 fm_carrier@me.com
Contact: Monique Ruel, RN 514-890-8000 ext 12171 monique.m.ruel.chum@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montréal, Quebec, Canada, H2X 3E4
Contact: Monique Ruel, RN    514-890-8000 ext 12171    monique.m.ruel.chum@ssss.gouv.qc.ca   
Contact: Julie Desroches, PhD    514-890-8000 ext 12172    julie.desroches.chum@ssss.gouv.qc.ca   
Sub-Investigator: Annie Deshêtres, MD         
Sub-Investigator: Michaël Chassé, MD         
Sub-Investigator: Benjamin Rioux-Massé, MD         
Sub-Investigator: Luc Massicotte, MD         
Principal Investigator: François Martin Carrier, MD         
France
Hopital Paul-Brousse Recruiting
Villejuif, France, 94800
Contact: Alexandre Joosten, MD       joosten-alexandre@hotmail.com   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Hopital Paul Brousse
Investigators
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Principal Investigator: François Martin Carrier, MD, MSc Centre hospitalier de l'Université de Montréal (CHUM)
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04925843    
Other Study ID Numbers: 19.115
First Posted: June 14, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Intraoperative Complications