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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis, Liver

Treatments: Procedure: Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure; Procedure: Conventional transfusion methods to guide blood product transfusion pre invasive procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04460222

ILBS-Cirrhosis-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Rotational Thromboelastometry (ROTEM)

Experimental group

Description:

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

Treatment:

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

Conventional Transfusion

Active Comparator group

Description:

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

Treatment:

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