TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
1 other identifier
interventional
96
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2016
CompletedStudy Start
First participant enrolled
February 15, 2016
CompletedFirst Posted
Study publicly available on registry
February 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2018
CompletedNovember 28, 2018
February 1, 2018
2 years
February 13, 2016
November 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
42 days
Secondary Outcomes (4)
Number of patients with bleed in both groups
5 days
Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
42 days
Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
42 days
Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
42 days
Study Arms (2)
Thromboelastography (TEG) level
EXPERIMENTALCoagulation Profile
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age more than 18
- All patient with Non Variceal bleed (INR\>1.8 and platelets\<50000)
- Hist logical or imaging proven liver cirrhosis.
You may not qualify if:
- Variceal Bleed,
- Pregnancy.,
- Patients on anticoagulation
- Patients who refused to participate in the study
- Post EVL ulcer bleed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Related Publications (1)
Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.
PMID: 31148204DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Juned Ahmad, MD
Institute of Liver and Biliary Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2016
First Posted
February 23, 2016
Study Start
February 15, 2016
Primary Completion
March 3, 2018
Study Completion
March 3, 2018
Last Updated
November 28, 2018
Record last verified: 2018-02