Back to resultsTEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
Primary Purpose
Non Variceal Bleed
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Fresh Frozen Plasma
Platelets Concentrate
Cryo Precitipitate
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Variceal Bleed
Eligibility Criteria
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:
- Variceal Bleed,
- Pregnancy.,
- Patients on anticoagulation
- Patients who refused to participate in the study
- Post EVL ulcer bleed
Sites / Locations
- Institute of Liver & Biliary Sciences
- Institute of liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thromboelastography (TEG) level
Coagulation Profile
Arm Description
Outcomes
Primary Outcome Measures
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
Secondary Outcome Measures
Number of patients with bleed in both groups
Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
Full Information
NCT ID
NCT02689232
First Posted
February 13, 2016
Last Updated
November 26, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02689232
Brief Title
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
Official Title
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
March 3, 2018 (Actual)
Study Completion Date
March 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Variceal Bleed
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thromboelastography (TEG) level
Arm Type
Experimental
Arm Title
Coagulation Profile
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Fresh Frozen Plasma
Intervention Type
Biological
Intervention Name(s)
Platelets Concentrate
Intervention Type
Biological
Intervention Name(s)
Cryo Precitipitate
Primary Outcome Measure Information:
Title
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Number of patients with bleed in both groups
Time Frame
5 days
Title
Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
Time Frame
42 days
Title
Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
Time Frame
42 days
Title
Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Variceal Bleed,
Pregnancy.,
Patients on anticoagulation
Patients who refused to participate in the study
Post EVL ulcer bleed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Juned Ahmad, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31148204
Citation
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.
Results Reference
derived
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TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
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