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

NCT04460222 | Completed

• 1 other identifier: ILBS-Cirrhosis-26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ROTEM; Transfusion; Pre invasive procedure; Coagulation disorders; Pediatric liver disease

Outcome Measures

Primary Outcomes (1)

• Comparison in the amount of blood products transfused between the groups

  To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis

  24 hours

Secondary Outcomes (6)

• Comparison in the amount of FFP transfused between the groups

  24 hours

• Comparison in the amount of Platelet transfused between the groups

  24 hours

• Comparison in the amount of Cryoprecipitate transfused between the groups

  24 hours

• Post-procedure bleeding

  24 hours

• Transfusion related side effects

  5 days

Study Arms (2)

Rotational Thromboelastometry (ROTEM)

EXPERIMENTAL

To prevent bleeding during invasive procedure, cirrhotic children in the ROTEM group will receive prophylactic transfusion based on the following protocol:- EXTEM CT \> 80 sec - FFP will be transfused at 15 ml/kg MCF \< 35 mm- Platelet will be transfused at 10 ml/kg FIBTEM MCF \< 7 mm- Cryoprecipitate will be transfused at 5 ml/kg

Procedure: Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure

Conventional Transfusion

ACTIVE COMPARATOR

To prevent bleeding during the procedure, cirrhotic children in the conventional group will receive prophylactic transfusion if either FFP, Platelet or Cryoprecipitate is deranged based on the following protocol * 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

Procedure: Conventional transfusion methods to guide blood product transfusion pre invasive procedure

Interventions

Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure 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

Rotational Thromboelastometry (ROTEM)

Conventional transfusion methods to guide blood product transfusion pre invasive procedure 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

Conventional Transfusion

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet 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
• Endoscopic variceal ligation (EVL)
• Endoscopic sclerotherapy (EST)
• High risk of bleeding 6. TIPPS 7. Endoscopic retrograde cholangiopancreatography (ERCP) with sphicterotomy 8. Percutaneous drain (PCD) Insertion 9. Biopsies other than liver biopsy
• For children less than 18 years with liver cirrhosis and with a platelet count between 40,000-60,000/mm3 and INR between 1.5-2.0 who are listed for
• \) Liver biopsy

You may not qualify if:

• Anti platelet or anti coagulant therapy in the previous 7 days
• Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or active bleeding
• Hemodialysis in the past 7 days

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• Maria A, Lal BB, Khanna R, Sood V, Mukund A, Bajpai M, Alam S. Rotational thromboelastometry-guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial. Liver Int. 2022 Nov;42(11):2492-2500. doi: 10.1111/liv.15398. Epub 2022 Aug 25.

  PMID: 35977053 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: November 16, 2020
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: June 15, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)