Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Nov 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating patients with acute on chronic liver failure (ACLF) who are experiencing severe bleeding from their stomach or esophagus. The researchers want to find out if using a special test called rotational thromboelastometry (or ROTEM) to guide treatment can help reduce the need for blood transfusions, lower the amount of bleeding, and decrease complications related to blood transfusions. They will compare this new method to standard treatment, which relies on traditional tests and clinical judgment.

To participate in this study, individuals must be between 18 and 65 years old and diagnosed with ACLF, specifically experiencing upper gastrointestinal bleeding. However, certain patients, like those who have recently received a blood transfusion or have specific health conditions (such as HIV, active cancer, or severe kidney issues), will not be eligible. Participants can expect to be monitored for any rebleeding or complications after their treatment, helping researchers learn more about the effectiveness and safety of this new approach. Additionally, the study aims to better understand how this method affects each patient's ability to stop bleeding after surgery.

Gender

ALL

Eligibility 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