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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153082
• Other study ID #: ILBS-Cirrhosis-69
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 25, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Saurav Paul, MD
• Phone: 01146300000
• Email: saurav.paul79[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

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
• 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°.

Locations

Country	Name	City	State
India	Dr Saurav Paul	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	Cumulative volume of FFP transfused at Day 5.		Day 5
Secondary	Cumulative volume of Cryoprecipitate in both groups		6 weeks
Secondary	Cumulative volume of Platelet in both groups		6 weeks
Secondary	Cumulative volume of Trenaxemic acid Transfusion related reactions in both groups		6 weeks
Secondary	Duration of intensive care unit (ICU) in both groups		6 weeks
Secondary	Duration of hospital stay in both groups		6 weeks
Secondary	Survival in both groups at 6 weeks		6 weeks