Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Non-variceal Bleeding.

NCT ID: NCT06153082

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-16
• Study Completion Date: 2024-12-31

Brief Summary

This study is aim to compare ROTEM and TEG guided coagulopathy correction in cirrhosis with non- variceal bleed.There are no other study in literature to compare this two group in cirrhosis with non-variceal bleed.This study will also assess the volume of blood product transfused with this two groups and it will compare among two groups.This will lessen the blood product transfusion and risk of transfusion relatedated complication.

Detailed Description

AIM:- To compare Rotational thrombo- elastometry vs Thrombo- elastography as a guide for blood component transfusion in patients of Cirrhosis with nonvariceal bleeding.

Methodology:- After fulfilling all inclusion and exclusion criteria, patients were randomized to either the TEG or ROTEM group in a 1:1 proportion. Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.In ROTEM group if CT EXTEM >80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM <35 and MCF FIBTEM <8 CRYO or Fibrinogen concentrate, if MCF EXTEM<35 and MCF FIBTEM >8 Platelet, CL LY>50 Trenaxemic acid

Study population: patients with Cirrhosis of liver with nonvariceal bleeding Study design: Randomized controlled trial Study period: 1 years after ethical clearance

Sample size: Assuming that total volume of FFP used in TEG 760 ± 370 and further in ROTEM volume used 510±275 with α 5% power 90, we need to enrol 72 cases. Further assuming 10% inadequacy We had decided to enroll a total of 80 patients, 40 in each group.The allocation will be done randomly by block randomization method.

Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.

STATISTICAL ANALYSIS:

The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The categorical data will be analyzed using Chi square/Fissure test. Exact test and continuous data will be compiled using t-test. Besides this the univariate and multivariate survival analysis will be carried out using Cox regression method. Kaplan-Meier technique will be applied for further analysis. P-value<0.05 will be considered as significant.

Adverse effects:Transfusion related complication

Stopping rule: If patient decided to withdraw from study

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ROTEM Group

In ROTEM group if CT EXTEM \>80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM \<35 and MCF FIBTEM \<8 CRYO or Fibrinogen concentrate, if MCF EXTEM\<35 and MCF FIBTEM \>8 Platelet, CL LY\>50 Trenaxemic acid.

Group Type: EXPERIMENTAL

ROTEM

Intervention Type: DIAGNOSTIC_TEST

In ROTEM group if CT EXTEM \>80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM \<35 and MCF FIBTEM \<8 CRYO or Fibrinogen concentrate, if MCF EXTEM\<35 and MCF FIBTEM \>8 Platelet, CL LY\>50 Trenaxemic acid

THROMBOELASTOGRAPHY

Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°

Group Type: ACTIVE_COMPARATOR

Thromboelastography

Intervention Type: DIAGNOSTIC_TEST

Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.

Interventions

ROTEM

In ROTEM group if CT EXTEM \>80S FFP at dose of 10ml/kg or PCC 20-25IU/kg ,if MCF EXTEM \<35 and MCF FIBTEM \<8 CRYO or Fibrinogen concentrate, if MCF EXTEM\<35 and MCF FIBTEM \>8 Platelet, CL LY\>50 Trenaxemic acid

Intervention Type: DIAGNOSTIC_TEST

Thromboelastography

Patients in the TEG group received blood components using the following triggers: FFP at a dose of 10 mL/kg of ideal body weight when reaction time (R time) was greater than 10 minutes; a single-donor apheresis platelet (SDAP) unit, which corresponds to approximately 6 to 8 pooled units of PLTs, transfused when the maximum amplitude (MA) was less than 55 mm; and cryoprecipitate (5 pooled units) transfused when the alpha angle was less than 45°.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients with Cirrhosis of any etiology

2. Age between 18 and 80 years;

3. Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing

4. bleed form a nonvariceal source); and

5. Significant coagulopathy assessed by CCTs (INR > 1.8 and/or PLTs < 50 × 109/L).

Exclusion Criteria

1. Variceal bleed

2. Post Variceal ligation ulcer bleed

3. Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel;

4. Anti-PLT or anticoagulant therapy at the time of enrollment or that had been discontinued less than 7 days before evaluation for the study;

5. Pregnancy

6. Significant cardiopulmonary diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr Saurav Paul

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Saurav Paul, MD

Role: CONTACT

saurav.paul79@gmail.com

01146300000

Facility Contacts

Dr Saurav Paul, MD

Role: primary

saurav.paul79@gmail.com

01146300000

Other Identifiers

ILBS-Cirrhosis-69

Identifier Type: -

Identifier Source: org_study_id