Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation

NCT ID: NCT04472312

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2022-07-06

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).

Conditions

Liver Transplantation; Portal Hypertension; Blood Transfusion; Blood Loss, Surgical

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cirrhotic patients undergoing a liver transplantation

The investigators aim to conduct a prospective observational, non-interventional study including all cirrhotic patients undergoing a liver transplantation with a planned use of vasopressin during the surgery.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François-Martin Carrier, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

20.121

Identifier Type: -

Identifier Source: org_study_id