Clinical trial NCT05583539: Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis
Official title: A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cirrhosis, Liver
Coagulopathy
GastroIntestinal Bleeding
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Volume of fresh frozen plasma transfused
timeFrame: From time of randomization to hospital discharge, up to 3 months
Secondary outcomes:
measure: Patients requiring fresh frozen plasma transfusion
timeFrame: From time of randomization to hospital discharge, up to 3 months
measure: Volume of platelets and cryoprecipitate transfused
timeFrame: From time of randomization to hospital discharge, up to 3 months
measure: Control of bleeding at 5 days
timeFrame: Measured at 5 days from the time of octreotide order placement
measure: Rebleeding at 42 days
timeFrame: The earlier of 42 days from the time of octreotide placement or hospital discharge
measure: Mortality rate during index hospitalization
timeFrame: From time of randomization to hospital discharge, up to 3 months
Other outcomes:
measure: Rate of transfusion reactions
timeFrame: From time of randomization to hospital discharge, up to 3 months
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd Rice, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rout G, Shalimar, Gunjan D, Mahapatra SJ, Kedia S, Garg PK, Nayak B. Thromboelastography-guided Blood Product Transfusion in Cirrhosis Patients With Variceal Bleeding: A Randomized Controlled Trial. J Clin Gastroenterol. 2020 Mar;54(3):255-262. doi: 10.1097/MCG.0000000000001214.
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