Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis

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.

Official Title
-----------------
A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding

Conditions
-----------------
Cirrhosis, Liver, Coagulopathy, GastroIntestinal Bleeding

Intervention / Treatment
-----------------
* Diagnostic Test: Thromboelastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Patients will receive usual care at the discretion of their providers. | |
| Experimental: Thromboelastography guided resuscitation<br>Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation. | Diagnostic Test: Thromboelastography<br>* Thromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of fresh frozen plasma transfused | The total volume of fresh frozen plasma transfused | From time of randomization to hospital discharge, up to 3 months | 

Secondary Outcome Measures

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