Rotational Thromboelastometry [ROTEM] vs Thromboelastography [TEG] Guided Blood Component Use in Patients With Cirrhosis of Liver With Nonvariceal Bleeding: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients with Cirrhosis of any etiology
• Age between 18 and 80 years;
• Presenting with nonvariceal upper GI bleeding (diagnosed after doing upper GI endoscopy, which showed ongoing
• bleed form a nonvariceal source); and
• Significant coagulopathy assessed by CCTs (INR \> 1.8 and/or PLTs \< 50 × 109/L).
Locations
Other Locations
India
Dr Saurav Paul
RECRUITING
New Delhi
Contact Information
Primary
Dr Saurav Paul, MD
saurav.paul79@gmail.com
01146300000
Time Frame
Start Date: 2023-12-16
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 80
Treatments
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.
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°
Related Therapeutic Areas
Sponsors
Leads: Institute of Liver and Biliary Sciences, India