Cirrhosis, Liver, Coagulopathy, GastroIntestinal Bleeding
Conditions
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.
Interventions
DIAGNOSTIC_TESTThromboelastography
Thromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of transfusion reactions | From time of randomization to hospital discharge, up to 3 months | Percentage of patients who experienced a transfusion reaction |
Outcome results
None listed