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

Non Variceal Bleed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689232
• Other study ID #: ILBS-Variceal Bleed-001
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: March 3, 2018

Study information

• Verified date: February 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 3, 2018
• Est. primary completion date: March 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Non Variceal Bleed

Intervention

Biological:
• Fresh Frozen Plasma

• Platelets Concentrate

• Cryo Precitipitate

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of FFP (Fresh Frozen Plasma) transfusion in both groups		42 days
Secondary	Number of patients with bleed in both groups		5 days
Secondary	Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.		42 days
Secondary	Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.		42 days
Secondary	Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.		42 days