Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis

Not Applicable

Withdrawn

• Conditions: Cirrhosis, Liver; GastroIntestinal Bleeding; Coagulopathy
• Interventions: Diagnostic Test: Thromboelastography

• Registration Number: NCT05583539
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

The goal of this clinical trial is to compare resuscitation strategies in patients with cirrhosis and gastrointestinal bleeding. The main question it aims to answer is whether thromboelastography guided resuscitation decreased the amount of fresh frozen plasma patients receive. Patients will receive blood products guided by thromboelastography in the intervention group. Researchers will compare the patients who undergo thromboelastography guided resuscitation to those who receive usual care to see which strategy leads to the use of less blood products, specifically less fresh frozen plasma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Study Start: 2025-01-16
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient aged 18 years or older
• Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thromboelastography guided resuscitation	Thromboelastography	Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation.

Primary Outcome Measures

Name	Time	Method
Volume of fresh frozen plasma transfused	From time of randomization to hospital discharge, up to 3 months	The total volume of fresh frozen plasma transfused

Secondary Outcome Measures

Name	Time	Method
Patients requiring fresh frozen plasma transfusion	From time of randomization to hospital discharge, up to 3 months	Percentage of patients requiring a fresh frozen plasma transfusion
Control of bleeding at 5 days	Measured at 5 days from the time of octreotide order placement	Percentage of patients who have bleeding controlled at 5 days
Rebleeding at 42 days	The earlier of 42 days from the time of octreotide placement or hospital discharge	Percentage of patients who experienced in-hospital rebleeding within 42 days
Volume of platelets and cryoprecipitate transfused	From time of randomization to hospital discharge, up to 3 months	The total combined volume of platelets and cryoprecipitate transfused
Mortality rate during index hospitalization	From time of randomization to hospital discharge, up to 3 months	Percentage of patients who died during the index hospitalization