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A study to understand the role of thromboelastography in guiding transfusion in patients with cirrhosis.

Thromboelastography guided vs. On-demand blood product transfusion in patients with cirrhosis undergoing high-risk invasive procedures: A Randomized Controlled Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033464
Enrollment
87
Registered
2021-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Thromboelastography guided transfusion of blood products.: Group 1: Thromboelastography guided transfusion of blood products. Patients will receive platelets when maximal amplitude (MA)

Sponsors

Dr Shalimar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. cirrhosis patients (age: 18-65 years) with platelet count ( <50,000/mm3) irrespective on INR values undergoing elective high-risk procedures.

Exclusion criteria

Exclusion criteria: 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 8. Any infection/Sepsis. 9. Acute-on chronic liver failure 10. Acute Kidney Injury 11. Chronic Kidney Disease

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1.To compare the proportion of patients with post-procedure bleeding within 5 days among the three groups. 2.To compare the proportion of patients with post-procedure bleeding within 28 days among the three groups. 3.To compare the proportion of patients with bleed-related mortality within 28 days among the three groups 4.To compare the proportion of patients needing PRBC transfusion within 5 days among the three groups.Timepoint: 1. 05 days 2. 28 days 3. 28 days 4. 05 days—

Countries

India

Contacts

Public ContactDr Shalimar

All India Institute of Medical Sciences

drshalimar@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026