Using a new method to guide blood transfusions in patients with liver failure and bleeding
Thromboelastometry Guided Transfusion Protocol Versus Standard Care in Acute-on-Chronic Liver Failure with Bleeding: a Prospective Intervention Trial
This study is testing a new way to guide blood transfusions for people with liver failure who are bleeding to see if it can help them need fewer transfusions and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh, Choose Any State/Province) |
| Trial ID | NCT05124041 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a rotational thromboelastometry-guided algorithm for hemostatic resuscitation in patients with acute on chronic liver failure (ACLF) experiencing variceal bleeding. The study will enroll 260 patients, randomly assigning them to either a conventional treatment group or a ROTEM-based treatment group. The primary focus is to assess whether the ROTEM-guided approach reduces the need for blood transfusions, minimizes bleeding, and decreases complications related to transfusions. Patients will be monitored for rebleeding, transfusion-related complications, and infections following hospitalization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with ACLF and active variceal bleeding.
Not a fit: Patients who have received a blood transfusion in the last two weeks or are HIV positive may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for blood transfusions and associated complications in patients with ACLF.
How similar studies have performed: Previous studies have indicated potential benefits of viscoelastic testing in similar patient populations, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient with ACLF with variceal bleeding is eligible for the study if one or more of the criteria are met following primary endoscopic intervention. 1. Multiple sites of bleed e.g. diffuse mucosal ooze, post EVL ulcers, diffuse portal hypertensive gastropathy, etc which are associated with coagulation dysfunction against a background of portal hypertensive bleeding 2. Failure to control bleeding 3. Early rebleeding 4. Active bleeding on endoscopy with refractory variceal bleeding, need for balloon tamponade or self expandable metal stents (SEMS) 5. At the time of bridge therapy to a more definite treatment such as PTFE covered TIPS. If one of the above criteria is met, then the patient is enrolled provided they meet the criteria below. Inclusion Criteria: * Age 18-65 years * ACLF, as diagnosed by CANONIC/ APASL criteria . * Upper gastrointestinal bleeding Exclusion Criteria: * Current therapy: Recent blood or blood component transfusion in the last 2 weeks. * HIV positive/ AIDS patients * Patients requiring antiplatelet therapy, * Renal insufficiency requiring dialysis * Active malignancy within the last 5 years * Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease * Administration of anticoagulants, antifibrinolytics, * Not willing to participate in the study
Where this trial is running
Chandigarh, Choose Any State/Province
- Postgraduate Institute of Medical Education and Research — Chandigarh, Choose Any State/Province, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.