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

Preoperative plasma transfusion versus no plasma transfusion strategies in cirrhosis patients with prolong INR level undergoing prophylactic esophageal band ligation: An open-label, randomized non-inferiority multi-center trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220921003
Enrollment
1100
Registered
2022-09-21
Start date
2022-10-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis patients with prolong clotting time Plasma transfusion Cirrhosis Restrictive Bleeding

Interventions

No plasma transfusion in cirrhosis patients with prolonged clotting time who undergo an invasive procedure.,2 units of plasma will be transfused in cirrhosis patients with prolonged clotting time who
Experimental No treatment,No Intervention Procedure/Surgery
Restrictive FFP transfusion,Conventional FFP transfusion

Sponsors

Chulalongkorn University
Lead Sponsor
The Royal College Physicians of Thailand
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Bleeding complication rate At 2 weeks after end of the intervention Major bleeding according to ISTH definition

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactNuanrat Cheerasiri

Department of Medicine, Faculty of Medicine, Chulalongkorn University, and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand

nuanrat.t@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026