TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.

November 26, 2018 updated by: Institute of Liver and Biliary Sciences, India

TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.

All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences
      • New Delhi, Delhi, India, 110070
        • Institute of Liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age more than 18
  • All patient with Non Variceal bleed (INR>1.8 and platelets<50000)
  • Hist logical or imaging proven liver cirrhosis.

Exclusion Criteria:

  1. Variceal Bleed,
  2. Pregnancy.,
  3. Patients on anticoagulation
  4. Patients who refused to participate in the study
  5. Post EVL ulcer bleed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thromboelastography (TEG) level
Biological: Fresh Frozen Plasma
Biological: Platelets Concentrate
Biological: Cryo Precitipitate
Active Comparator: Coagulation Profile
Biological: Fresh Frozen Plasma
Biological: Platelets Concentrate
Biological: Cryo Precitipitate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with bleed in both groups
Time Frame: 5 days
5 days
Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
Time Frame: 42 days
42 days
Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
Time Frame: 42 days
42 days
Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Investigators

  • Principal Investigator: Dr Juned Ahmad, MD, Institute of Liver and Biliary Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

March 3, 2018

Study Completion (Actual)

March 3, 2018

Study Registration Dates

First Submitted

February 13, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-Variceal Bleed-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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