Comparing ROTEM and standard tests for bleeding risk in children with liver disease
Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures:A Randomised Controlled Trial
This study is testing if a new blood test called ROTEM can better predict bleeding risks and transfusion needs in children with liver disease who are having medical procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi) |
| Trial ID | NCT05734001 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of rotational thromboelastometry (ROTEM) compared to conventional haemostatic tests in children aged 6 months to 18 years with decompensated cirrhosis who are undergoing various invasive procedures. The study aims to determine whether ROTEM can provide a more accurate assessment of bleeding risk and transfusion needs, potentially leading to better patient outcomes. Participants will be randomly assigned to receive either standard transfusion protocols based on conventional tests or ROTEM-guided transfusions. The trial is set to run for two years, from October 2022 to October 2024.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 18 years with decompensated cirrhosis and specific INR and platelet count criteria listed for invasive procedures.
Not a fit: Patients currently on anti-platelet or anti-coagulant therapy, those with active bleeding, or those who have undergone hemodialysis in the past week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved transfusion strategies and reduced bleeding complications in children with decompensated cirrhosis undergoing invasive procedures.
How similar studies have performed: While the use of ROTEM in this context is relatively novel, similar studies have shown promising results in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children 6m- 18years of age * Histologic or image proven liver cirrhosis of any etiology * Listed for an invasive procedure Procedures 1. Central venous cannulation 2. Haemodialysis catheter 3. Ascitic or Pleural tapping 4. EVL/EST 5. TIPPS 6. ERCP with sphicterotomy 7. PCD Insertion 8. Biopsies other than liver biopsy : INR \>2.5 and/or PLT count 20,000/mm3- 50,000/mm3 9. Those listed for Liver Biopsy: INR \>2 and/or PLT count 20-50,000/mm3 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
Where this trial is running
New Delhi
- Institute of Liver and Biliary Sciences — New Delhi, India (Recruiting)
Study contacts
- Study coordinator: Snigdha Verma
- Email: dr.snigdha1@gmail.com
- Phone: 7427872290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.