CTRI/2020/11/029132CompletedPhase 3
Rotational Thromboelastometry( ROTEM) Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
ILBS hospital0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ââ?°Â¥ 1.5- ââ?°Â¤ 2.5 and/or PLT 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
- •High risk of bleeding
- •ERCP with sphicterotomy
- •PCD Insertion
- •Biopsies other than liver biopsy
- •Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ââ?°Â¥ 1.5- ââ?°Â¤ 2.0 and/or PLT count 40,000/mm3- 60,000/mm3 and who are listed for Liver biopsy
Exclusion Criteria
- •Anti platelet or anti coagulant therapy in the previous 7 days
- •Patients with clinical evidence of DIC and/or active bleeding
- •Hemodialysis in the past 7 days
Investigators
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