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Intraoperative Phlebotomies and Bleeding in Liver Transplantation (TOF_PHLEBO)

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ClinicalTrials.gov Identifier: NCT04826666
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Liver transplantation are surgeries associated with important bleeding and often require perioperative red blood cell (RBC) transfusions. Overall, between 20 and 85 % of liver transplant recipients receive at least one RBC transfusion during their surgery. Such transfusions are consistently associated with higher morbidity and mortality, although this causal association is still under debate in many surgical populations. Despite the lack of clear causative association between perioperative transfusions and worse outcomes, minimizing bleeding and transfusions is believed to improve postoperative outcomes. Many perioperative variables are associated with higher blood loss and need for perioperative transfusions: liver disease severity, preoperative anemia and coagulopathy, higher cardiac filling pressures and higher fluid administration, among others. However, few perioperative interventions have been shown to reduce bleeding and transfusion requirements in this population. Among them, the use of intraoperative phlebotomies to reduce portal and hepatic venous pressure during the dissection phase is a promising one, also described in liver resection surgery.

To further investigate the effects of intraoperative phlebotomies on intraoperative bleeding, perioperative transfusions and mortality, the Principal Investigator will conduct a retrospective cohort study with a propensity score based causal analysis.


Condition or disease
Liver Diseases Liver Cirrhosis Surgery Surgery--Complications Postoperative Complications Transplant; Failure, Liver

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intraoperative Phlebotomies and Bleeding in Liver Transplantation: a Retrospective Cohort Study and Causal Analysis Protocol
Actual Study Start Date : March 31, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Groups/Cohorts
The Principal Investigator propose to conduct a retrospective observational cohort study of all consecutive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).



Primary Outcome Measures :
  1. Intraoperative bleeding [ Time Frame: During the liver transplantation ]
    The intervention of interest is aimed at reducing bleeding. Even though intraoperative bleeding measurement is subject to measurement error, such measurement is homogeneously done through a cellsaver device at the CHUM..


Secondary Outcome Measures :
  1. Perioperative red blood cell transfusions [ Time Frame: Up to 48 hours after liver transplantation ]
    Clinicians conducting the intervention are also the ones who make decision regarding intraoperative red blood cell transfusions. Thus, perioperative red blood cell transfusions will be used as a secondary outcome (intraoperative + postoperative up to 48 hours) in case patients who received a phlebotomy were less transfused only because anesthesiologist decided not to transfuse (differential "classification" bias)

  2. Any intraoperative red blood cell transfusions [ Time Frame: During the liver transplantation ]
    Clinicians conducting the intervention are also the ones who make decision regarding intraoperative red blood cell transfusions

  3. Survival up to 1 year after liver transplantation [ Time Frame: 1 year after liver transplantation ]
    Survival was calculated from the date of liver transplantation to the date of recipient's death due to any cause, within 1 year after the surgery.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).
Criteria

Inclusion Criteria:

- All successive adult patients who underwent a liver transplantation between July 2008 and January 2021 at the Centre hospitalier de l'Université de Montréal (CHUM).

Exclusion Criteria:

- All patients who were under renal replacement therapy prior to surgery as well as those who had a glomerular filtration rate below 30 mL/h (based on MDRD formula).


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): NCT04826666


Contacts
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Contact: François-Martin Carrier, MD, FRCPC 514-890-8000 ext 12131 francois.martin.carrier@umontreal.ca
Contact: Eva Amzallag, M.Sc. 514-890-8000 ext 12131 eva.amzallag.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: Eva Amzallag, M.Sc.       eva.amzallag.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: François-Martin Carrier, MD, FRCPC 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: NCT04826666    
Other Study ID Numbers: 20.436
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: March 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
Liver Cirrhosis
Postoperative Complications
Pathologic Processes
Digestive System Diseases