A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Volume of fresh frozen plasma transfused
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged 18 years or older
- •Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Volume of fresh frozen plasma transfused
Time Frame: From time of randomization to hospital discharge, up to 3 months
The total volume of fresh frozen plasma transfused
Secondary Outcomes
- Patients requiring fresh frozen plasma transfusion(From time of randomization to hospital discharge, up to 3 months)
- Control of bleeding at 5 days(Measured at 5 days from the time of octreotide order placement)
- Rebleeding at 42 days(The earlier of 42 days from the time of octreotide placement or hospital discharge)
- Volume of platelets and cryoprecipitate transfused(From time of randomization to hospital discharge, up to 3 months)
- Mortality rate during index hospitalization(From time of randomization to hospital discharge, up to 3 months)
Investigators
Todd Rice
Professor of Medicine
Vanderbilt University Medical Center