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

NCT04472312 | Completed

• 1 other identifier: 20.121
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intraoperative blood loss

  At the end of the surgery

• Packed red blood cell transfusion rates

  Intraoperatively and up to 24 hours following surgery

• Rate of acute kidney injury (AKI) grade 2 or 3

  Assessed at 24 hours and 48 hours following surgery

• Rate of new renal therapy replacement

  Postoperative setting up to 7 days following surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Hypertension, Portal; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• François-Martin Carrier, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 15, 2020
• Study Start: August 24, 2020
• Primary Completion: June 29, 2022
• Study Completion: July 6, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

CA (1)