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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460222
• Other study ID #: ILBS-Cirrhosis-26
• Status: Completed
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: March 28, 2022

Study information

• Verified date: June 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

Intervention

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
• 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

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Post-procedure bleeding	Comparison of the number of patients having bleeding episodes after procedure between the study groups	24 hours
Secondary	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
Secondary	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