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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02689232
Enrollment
96
Registered
2016-02-23
Start date
2016-02-15
Completion date
2018-03-03
Last updated
2018-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Variceal Bleed

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.

Interventions

BIOLOGICALFresh Frozen Plasma
BIOLOGICALPlatelets Concentrate
BIOLOGICALCryo Precitipitate

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups42 days

Secondary

MeasureTime frame
Number of patients with bleed in both groups5 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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026