Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation

NCT06749405 | Recruiting

• 2 other identifiers: RC31/23/06212024-A00944-43
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation carries a substantial risk of bleeding, making precise haemostasis control essential, although assessing coagulation remains challenging. Quantra, a bedside viscoelastic testing device using sonorheometric methods, offers an innovative approach to guiding haemostatic management during surgery. The study aims to determine whether a Quantra-guided transfusion can reduce transfusion and bleeding during liver transplantation when compared to a conventional transfusion approach.

Conditions

Liver Transplantation

Keywords

Liver transplantation; Bleeding; Blood transfusion; Quantra®; Viscoelastic test; Haemorrhagic surgery; Labile blood products; Randomized controlled trial; Coagulation; End-stage liver disease (ESLD)

Outcome Measures

Primary Outcomes (1)

• Fresh Frozen Plasma (FFP) transfusion during liver transplantation surgery

  Number of FFP transfused intraoperatively during liver transplantation surgery.

  Conducted during surgery

Study Arms (2)

Transfusion algorithm based on Quantra®

EXPERIMENTAL

Patients managed using a transfusion algorithm based on Quantra®.

Biological: Transfusion algorithm based on Quantra®

Conventional transfusion algorithm

ACTIVE COMPARATOR

Patients managed using a conventional transfusion algorithm.

Biological: Conventional transfusion algorithm

Interventions

Transfusion algorithm based on Quantra® BIOLOGICAL

In addition to routine coagulation tests, a Quantra Qstat® analysis will be performed at baseline (before incision), at the end of native liver dissection, and after unclamping of the venous anastomoses. In the event of bleeding, additional Quantra Qstat® analyses may be conducted until bleeding control is achieved. Transfusion and administration of blood-derived medications will be guided by the results of the Quantra Qstat® analyses.

Transfusion algorithm based on Quantra®

Conventional transfusion algorithm BIOLOGICAL

Transfusion and blood-derived medications will be guided by the results of routine coagulation tests.

Conventional transfusion algorithm

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older
• Patient with ESLD undergoing liver transplantation
• Individuals affiliated with or beneficiaries of a social security scheme
• Free and informed written consent obtained in writing from the patient, or where applicable from the trusted person/family member/close relative
• Multi-organ transplantation
• Congenital haemostasis disorder (such as haemophilia)
• Patient under juridical protection (persons deprived of liberty or under curatorship or guardianship or safeguard of justice)
• Pregnant or breast-feeding woman
• Patient already enrolled in another interventional study with primary or secondary objective of reducing perioperative bleeding or transfusion

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Thrombosis; End Stage Liver Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Guillaume PORTA BONETE, Md

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume PORTA BONETE, Md

CONTACT

561323565; porta-bonete.g@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Intervention Group: Patients managed using a transfusion algorithm based on Quantra® * Control Group: Patients managed using a conventional transfusion algorithm

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: March 8, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (1)