Intraoperative Phlebotomies and Bleeding in Liver Transplantation (TOF_PHLEBO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04826666|
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : November 9, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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|
|Study Type :||Observational|
|Actual Enrollment :||679 participants|
|Official Title:||Intraoperative Phlebotomies and Bleeding in Liver Transplantation: a Retrospective Cohort Study and Causal Analysis Protocol|
|Actual Study Start Date :||March 31, 2021|
|Actual Primary Completion Date :||November 4, 2021|
|Actual Study Completion Date :||November 4, 2021|
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).
- 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..
- 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)
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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).
- 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).
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
|Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montréal, Quebec, Canada, H2X 3E4|
|Principal Investigator:||François-Martin Carrier, MD, FRCPC||Centre hospitalier de l'Université de Montréal (CHUM)|
|Responsible Party:||Centre hospitalier de l'Université de Montréal (CHUM)|
|Other Study ID Numbers:||
|First Posted:||April 1, 2021 Key Record Dates|
|Last Update Posted:||November 9, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Diseases