Status:
COMPLETED
Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Cirrhosis, Liver
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief Summary
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests \[namely Internationa...
Detailed Description
Children with cirrhosis listed for invasive procedures and with deranged INR or deranged platelet count will be included in the study and will be block randomized into two groups. To prevent bleeding ...
Eligibility Criteria
Inclusion
- •Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet count 20,000/mm3- 50,000/mm3 and who are listed for the following invasive procedures : Low risk of bleeding
- Central venous cannulation
- Haemodialysis catheter
- Ascitic or Pleural tapping
- Endoscopic variceal ligation (EVL)
- Endoscopic sclerotherapy (EST)
- High risk of bleeding 6. TIPPS 7. Endoscopic retrograde cholangiopancreatography (ERCP) with sphicterotomy 8. Percutaneous drain (PCD) Insertion 9. Biopsies other than liver biopsy
- For children less than 18 years with liver cirrhosis and with a platelet count between 40,000-60,000/mm3 and INR between 1.5-2.0 who are listed for
- 1\) Liver biopsy
Exclusion
- Anti platelet or anti coagulant therapy in the previous 7 days
- Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or active bleeding
- Hemodialysis in the past 7 days
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04460222
Start Date
November 16 2020
End Date
March 28 2022
Last Update
June 15 2022
Active Locations (1)
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1
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070