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

Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Nonvariceal Bleeding: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Diagnostic test: ROTEM; Diagnostic test: Thromboelastography

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Saurav Paul, MD; Phone Number: 01146300000; Email: saurav.paul79@gmail.com

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Dr Saurav Paul
      • Contact: Dr Saurav Paul, MD; Phone Number: 01146300000; Email: saurav.paul79@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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
Active Comparator: 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°	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°.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative volume of FFP transfused at Day 5.	Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative volume of Cryoprecipitate in both groups	6 weeks
Cumulative volume of Platelet in both groups	6 weeks
Cumulative volume of Trenaxemic acid Transfusion related reactions in both groups	6 weeks
Duration of intensive care unit (ICU) in both groups	6 weeks
Duration of hospital stay in both groups	6 weeks
Survival in both groups at 6 weeks	6 weeks

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-69

Drug and device information, study documents

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