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

NCT ID: NCT02689232

Last Updated: 2018-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-15

Study Completion Date

2018-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Non Variceal Bleed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Thromboelastography (TEG) level

Group Type EXPERIMENTAL

Fresh Frozen Plasma

Intervention Type BIOLOGICAL

Platelets Concentrate

Intervention Type BIOLOGICAL

Cryo Precitipitate

Intervention Type BIOLOGICAL

Coagulation Profile

Group Type ACTIVE_COMPARATOR

Fresh Frozen Plasma

Intervention Type BIOLOGICAL

Platelets Concentrate

Intervention Type BIOLOGICAL

Cryo Precitipitate

Intervention Type BIOLOGICAL

Interventions

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Fresh Frozen Plasma

Intervention Type BIOLOGICAL

Platelets Concentrate

Intervention Type BIOLOGICAL

Cryo Precitipitate

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Juned Ahmad, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 31148204 (View on PubMed)

Other Identifiers

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ILBS-Variceal Bleed-001

Identifier Type: -

Identifier Source: org_study_id

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