Thromboelastometry Guided Transfusion Protocol Versus Standard Care in Acute-on-Chronic Liver Failure with Bleeding: a Prospective Intervention Trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 18-65 years

• ACLF, as diagnosed by CANONIC/ APASL criteria .

• Upper gastrointestinal bleeding

Locations
Other Locations
India
Postgraduate Institute of Medical Education and Research
RECRUITING
Chandigarh
Time Frame
Start Date: 2021-11-15
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 140
Treatments
Experimental: ROTEM-arm
Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis
Active_comparator: Control-arm
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
Related Therapeutic Areas
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov