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Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial

NCT04460222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-06-15

No results posted yet for this study

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 \[namely International Normalised Ratio (INR) and Platelets count\] are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in cirrhotic children undergoing invasive procedures.

Conditions

  • Cirrhosis, Liver

Interventions

PROCEDURE

Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure

Rotational Thromboelastometry will be performed pre procedure and blood component will be transfused if * EXTEM CT more than 80 sec then FFP will be transfused at 15 ml/kg MCF less than 35 mm then Platelet will be transfused at 10 ml/kg * FIBTEM MCF less than 7 mm then Cryoprecipitate will be transfused at 5 ml/kg

PROCEDURE

Conventional transfusion methods to guide blood product transfusion pre invasive procedure

Transfusion will be given If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg If Fibrinogen \< 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2022-03-28
Completion
2022-03-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460222 on ClinicalTrials.gov