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

Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation: the PORTAL Study.

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Portal Hypertension; Blood Loss, Surgical; Blood Transfusion

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).

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3E4
      • Centre hospitalier de l'Université de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Portal pressure measurement	The venous pressure in the liver will be measured by inserting a very fine needle in the portal vein. The needle will be connected to a pressure sensor and will be removed after the measurement. This measure will be performed at three different moments during the surgery; 1) as soon as possible after the incision; 2) 5 minutes after the end of the hypovolemic phlebotomy (if performed); 3) 10 minutes after the start of vasopressin infusion.	During the surgery (intraoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	During the liver transplantation, a cell salvage device (Cell Saver) will be set up in the operating room. As the surgery progresses, the blood lost by the patient will be collected using suctions. The volume of blood (mL) in the suctions will be measured at the end of the surgery, before the blood is cleaned and returned back to the patient.	At the end of the surgery
Packed red blood cell transfusion rates	Number of units of packed red blood cells transfused to participants will be recorded.	Intraoperatively and up to 24 hours following surgery
Rate of acute kidney injury (AKI) grade 2 or 3	The onset or worsening of acute postoperative grade 2 or 3 renal failure according to KDIGO-AKI criteria.	Assessed at 24 hours and 48 hours following surgery
Rate of new renal therapy replacement	Any need of new renal therapy replacement occurring during the hospital stay up to 7 days following surgery will be recorded.	Postoperative setting up to 7 days following surgery

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2020
• Primary Completion (ACTUAL): June 29, 2022
• Study Completion (ACTUAL): July 6, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (ACTUAL): July 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Hemorrhage; Liver Diseases; Intraoperative Complications; Hypertension, Portal; Blood Loss, Surgical
• Other Study ID Numbers: 20.121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No