A study to determine if a new method of testing blood clotting (thromboelastography) can help to predict how much blood transfusion is required in liver disease patients with variceal bleeding.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Cirrhosis with Variceal bleeding

• Registration Number: CTRI/2017/02/007864
• Lead Sponsor: Department of Gastroenterology AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-29
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Cirrhosis with acute variceal bleeding

2.Age between 18-65 years

3.Willing to participate in the study

Exclusion Criteria

1.Variceal bleeding secondary to causes other than cirrhosis. eg, extrahepatic venous obstruction, hepatic venous outflow track obstruction

2.Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (haemophilia) apart from cirrhosis.

3.History of intake of platelets inhibitors (eg, aspirin, clopidogrel) and drugs affecting coagulation cascade (eg, vitamin K anatagonists) within past 7 days

4.Pregnant women and those on oral contraceptives

5.Patients with chronic renal failure

6.History of underlying hypercoagulable/ hypocoagulable states eg. paroxysmal nocturnal hemoglobunuria (PNH), polycythemia vera etc

7.Patients receiving blood products (fresh frozen plasma and platelet prior to thromboelastography)

8.Patients with shock

9.Sepsis

10.Acute on chronic liver failure

11.Hepatorenal syndrome

12.Hepatic encephalopathy

13.Contraindication to endoscopy

14.Not willing to provide consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the requirement of blood products between the two groups.Timepoint: 24 hours, 120 hours

Secondary Outcome Measures

Name	Time	Method
1.Control of variceal bleeding at 24 hours and 5 days. <br/ ><br>2.Rebleeding and mortality at 6 weeks. <br/ ><br>Timepoint: 1.Control of variceal bleeding at 24 hours and 5 days. <br/ ><br>2.Rebleeding and mortality at 6 weeks. <br/ ><br>