CompletedNot Applicable

Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy

India262 participantsStarted 2021-11-15

Plain-language summary

In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured. We plan to enroll 260 patients having ACLF with variceal bleeding randomized into two groups: one will be treated conventionally using clinical judgement and standard coagulation tests such as prothrombin time, platelet count, etc. the other treated using a ROTEM-based algorithm. They will be followed for development of rebleeding, complications of transfusion and any signs of infection after hospitalization There will be a 'no intervention' group with well controlled bleeding who will undergo VETs but not be offered coagulation correction prophylactically in accordance with the Baveno VII consensus. This control group will be followed up in parallel with the main intervention groups. The ROTEM or SCT based correction will only be offered to patients who have high risk for rebleeding/ failure to control bleeding/ active bleeding at endoscopy/ need SEMS/TIPS and such individuals will be randomized to 2 arms ROTEM vs SCT, with 130 in each arm.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Active bleeding on endoscopy with refractory variceal bleeding, need for balloon tamponade or self expandable metal stents (SEMS) 4. 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

What they're measuring

Number of participants with clinical control of bleeding

Timeframe: 24 hours

Number of participants with clinical control of bleeding

Timeframe: 5 days

Number of participants with clinical control of bleeding

Timeframe: 42 days

Trial details

NCT IDNCT05124041

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Acute on Chronic Liver Failure trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.