Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cirrhosis, Liver
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 18 years
- Gender
- Both males and females
Description
Children with cirrhosis listed for invasive procedures and with deranged INR between 1.5-2,5 and/or deranged platelet count between 20,000/mm3-50,000/mm3 will be included in the study and will be block randomized into two groups. To prevent bleeding during the procedure, one group will receive proph...
Children with cirrhosis listed for invasive procedures and with deranged INR between 1.5-2,5 and/or deranged platelet count between 20,000/mm3-50,000/mm3 will be included in the study and will be block randomized into two groups. To prevent bleeding during the procedure, one group will receive prophylactic transfusion of either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR, platelet and fibrinogen.The second group will undergo ROTEM based correction. Following correction, the procedure will be done in both the groups. Patients randomized in the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on the component transfused), post the procedure, to look at the correction achieved. Similarly, patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen testing depending on the component transfused. Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion reaction.
Tracking Information
- NCT #
- NCT04460222
- Collaborators
- Not Provided
- Investigators
- Not Provided
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