NCT04460222

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Cirrhosis, Liver

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-16
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2020-07-07
• Last updated: 2022-06-15

Locations

1 site across 1 country: India