Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy

NCT05124041 | Completed DMC

• 2 other identifiers: PGI/IEC/2020/000268PGI/IEC/2024/EIC000462 27.3.24
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute on Chronic Liver Failure; Variceal Hemorrhage; Cirrhosis, Liver; Thromboelastometry; Thrombosis;Portal

Outcome Measures

Primary Outcomes (3)

• Number of participants with clinical control of bleeding

  Clinical control of bleeding at 24 hours, at Day 5 and day 42

  24 hours

• Number of participants with clinical control of bleeding

  Clinical control of bleeding at 24 hours, at Day 5 and day 42

  5 days

• Number of participants with clinical control of bleeding

  Clinical control of bleeding at 24 hours, at Day 5 and day 42

  42 days

Secondary Outcomes (4)

• Duration of Intensive care admission

  30 days after bleeding episode treated by transfusion protocol

• Duration of hospital stay

  30 days after bleeding episode treated by transfusion protocol

• Number of Participants with Transfusion-related side effects

  30 days after bleeding episode treated by transfusion protocol

• Number of Participants with Thromboembolic events

  30 days after bleeding episode treated by transfusion protocol

Study Arms (2)

ROTEM-arm

EXPERIMENTAL

Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis

Diagnostic Test: Rotational thromboelastometry

Control-arm

ACTIVE COMPARATOR

Treatment of significant blood loss conventionally, ie. using clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma

Diagnostic Test: Rotational thromboelastometry

Interventions

Rotational thromboelastometry DIAGNOSTIC_TEST

ROTEM-guided protocol of hemostatic resuscitation

Control-arm; ROTEM-arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• ACLF, as diagnosed by CANONIC/ APASL criteria .
• Upper gastrointestinal bleeding

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Choose Any State/Province, 160012, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 260 patients having ACLF with bleeding will be randomized into two groups. One will be treated conventionally, i.e. using clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm Revised Eligibility criteria as per Baveno VII ACLF with variceal bleeding with any indication for blood component transfusion as below Indications for transfusion in either arm are 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.

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 17, 2021
• Study Start: November 15, 2021
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

IN (1)