A study to understand the role of thromboelastography in guiding transfusion in patients with cirrhosis.
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2021/05/033464
- Lead Sponsor
- Dr Shalimar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. cirrhosis patients (age: 18-65 years) with platelet count ( <50,000/mm3) irrespective on INR values undergoing elective high-risk procedures.
1.Patients with malignancy (except hepatocellular cancer) /disseminated intravascular coagulation (DIC)/known coagulopathy (hemophilia),
2.Patients on platelets inhibitors or vitamin K antagonists within past 7 days,
3.Active oral contraceptive use
4.Pregnancy
5.Underlying hypercoagulable/ hypocoagulable states eg. paroxysmal nocturnal hemoglobinuria (PNH), polycythemia vera, etc,
6.Those who received blood products (fresh frozen plasma and/or platelet prior to thromboelastography)
7.Patients with shock (BP <90/60 mmHg), and
8.Any infection/Sepsis.
9.Acute-on chronic liver failure
10.Acute Kidney Injury
11.Chronic Kidney Disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the blood product requirement (Platelets + Cryoprecipitate) among the three groups (TEG guided, Empirical transfusion group, On-demand transfusion group)Timepoint: 05 days
- Secondary Outcome Measures
Name Time Method 1.To compare the proportion of patients with post-procedure bleeding within 5 days among the three groups. <br/ ><br>2.To compare the proportion of patients with post-procedure bleeding within 28 days among the three groups. <br/ ><br>3.To compare the proportion of patients with bleed-related mortality within 28 days among the three groups <br/ ><br>4.To compare the proportion of patients needing PRBC transfusion within 5 days among the three groups.Timepoint: 1. 05 days <br/ ><br>2. 28 days <br/ ><br>3. 28 days <br/ ><br>4. 05 days