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

Not Applicable

Completed

• Conditions: Non Variceal Bleed
• Interventions: Biological: Fresh Frozen Plasma; Biological: Platelets Concentrate; Biological: Cryo Precitipitate

• Registration Number: NCT02689232
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-13
• Study Start: 2016-02-15
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Status Verified: 2018-02
• Primary Completion: 2018-03-03
• Study Completion: 2018-03-03
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coagulation Profile	Cryo Precitipitate	-
Thromboelastography (TEG) level	Fresh Frozen Plasma	-
Thromboelastography (TEG) level	Platelets Concentrate	-
Thromboelastography (TEG) level	Cryo Precitipitate	-
Coagulation Profile	Fresh Frozen Plasma	-
Coagulation Profile	Platelets Concentrate	-

Primary Outcome Measures

Name	Time	Method
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups	42 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India