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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Procedure: Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure; Procedure: Conventional transfusion methods to guide blood product transfusion pre invasive procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

•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

1. Central venous cannulation
2. Haemodialysis catheter
3. Ascitic or Pleural tapping
4. Endoscopic variceal ligation (EVL)
5. 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

1) Liver biopsy

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotational Thromboelastometry (ROTEM); 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; 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
Active Comparator: Conventional Transfusion; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison in the amount of FFP transfused between the groups	To compare the amount of FFP (ml/kg) transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis	24 hours
Comparison in the amount of Platelet transfused between the groups	To compare the amount of Platelet transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis	24 hours
Comparison in the amount of Cryoprecipitate transfused between the groups	To compare the amount of Cryoprecipitate transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis	24 hours
Post-procedure bleeding	Comparison of the number of patients having bleeding episodes after procedure between the study groups	24 hours
Transfusion related side effects	- To compare the rate of transfusion reactions in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis	5 days
Comparison between blood products costs between groups	To compare the cost of transfusion components incurred in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis	24 hours

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Transfusion; ROTEM; Pre invasive procedure; Coagulation disorders; Pediatric liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No