Clinical trial NCT04472312: Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation
Official title: Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation: the PORTAL Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Portal Hypertension
Blood Transfusion
Blood Loss, Surgical
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to conduct a prospective observational, non-interventional study, respecting current practice. This study will take place at the Centre de recherche de l'Université de Montréal (CHUM) where there are approximately 70 to 80 liver transplants per year.

Brief summary: Liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. The intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. However, this hemorrhagic risk has been drastically reduced in the last 20 years and liver transplants without the use of blood products are now possible. Indeed, improvements in medical and surgical techniques associated with a better understanding of the pathophysiology of the cirrhotic patient have enabled this advance. One of the targeted therapeutic strategies is the control of portal hypertension. Several treatments have been sought, such as the use of splanchnic vasoconstrictors (such as vasopressin) and hypovolemic phlebotomy. These techniques reduce portal pressure and seem to reduce intraoperative bleeding with, even, a protective effect on kidney function. Their single-use or their combination is currently used in certain centers of expertise in liver transplantation. However, the hemodynamic effects of the combination of these 2 treatments on portal pressure has never been demonstrated. In this study, the effect of vasopressin, combined with a hypovolemic phlebotomy, on portal pressure in cirrhotic patients undergoing liver transplantation will be evaluated.

Detailed description: METHODS

Objectives

The primary objective will be to measure the hemodynamic effects of vasopressin on portal pressure in cirrhotic patients who have had a hypovolemic phlebotomy during a liver transplant.

The secondary objectives will be to measure the effects of vasopressin on portal pressure in patients who have not had a phlebotomy and to compare this effect between patients who have or have not had a hypovolemic phlebotomy.

The tertiary objective will be to assess the effect of the variation in portal pressure under vasopressin, associated or not with a hypovolemic phlebotomy, on hemorrhagic clinical outcomes (intraoperative bleeding and blood transfusions).

Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients undergoing a liver transplantation
* 18 years and older
* Planned use of vasopressin during the surgery

Exclusion Criteria:

* Fulminant or sub-fulminant hepatitis without underlying chronic liver disease
* Anesthetic plan does not include the use of vasopressin (contraindication or not relevant according to the anesthesiologist)

Primary outcomes:
measure: Portal pressure measurement
timeFrame: During the surgery (intraoperatively)
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: At the end of the surgery
measure: Packed red blood cell transfusion rates
timeFrame: Intraoperatively and up to 24 hours following surgery
measure: Rate of acute kidney injury (AKI) grade 2 or 3
timeFrame: Assessed at 24 hours and 48 hours following surgery
measure: Rate of new renal therapy replacement
timeFrame: Postoperative setting up to 7 days following surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: François-Martin Carrier, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: