Restrictive plasma transfusion in cirrhosis, a randomized non-inferiority multi-center trial

Phase 3

• Conditions: Cirrhosis patients with prolong clotting time; Plasma transfusion; Cirrhosis; Restrictive; Bleeding

• Registration Number: TCTR20220921003
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-21
• Last Update Posted: 19 August 2024
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

1. Cirrhosis patients diagnosed by clinical signs and/or liver function tests and/or imaging and/or liver biopsy, 2. Baseline international normalized ratio (INR) 1.5 to 2.5, 3. Have a history of esophageal varice, 4. Undergoing a prophylaxis esophageal band ligation.

Exclusion Criteria

1. Hereditary or acquired coagulopathy other than liver diseases, 2. Evidence of hemodynamic instability, 3. History of active infection within 2 weeks, 4. Renal insufficiency (Creatinine 2.0 mg/dL or over), 5. Taking antiplatelet and/or anticoagulant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bleeding complication rate At 2 weeks after end of the intervention Major bleeding according to ISTH definition

Secondary Outcome Measures

Name	Time	Method
Transfusion rate 24 hours after initiate the intervention The plasma transfusion event. Yes or No.,Transfusion-related adverse events Within 24 hr after end of the intervention National Healthcare Safety Network (NHSN) Hemovigilance Module,Mortality rates Within 3 months after end of the intervention Number of Mortality in each arm