The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Not Applicable

Terminated

• Conditions: Cirrhosis, Coagulopathy
• Interventions: Biological: Blood transfusion

• Registration Number: NCT02990273
• Lead Sponsor: Johns Hopkins University

Brief Summary

Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting in "rebalanced homeostasis". However, conventional blood tests (platelets/ INR levels) that are performed prior to invasive procedures do not accurately reflect the coagulation changes that occur in cirrhotics, resulting in unnecessary transfusion of blood products. Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in surgery (including liver transplant) to help guide blood product transfusion in the operating room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The investigators will evaluate to see if there is a decrease in prophylactic blood transfusions prior to endoscopy when using TEG.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Study Start: 2017-01
• Status Verified: 2021-01
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy

Exclusion Criteria

• Patients on blood thinners (prophylactic anticoagulation is permissible)
• Hemodynamically unstable patients requiring pressors (ie ICU level patients)
• Pregnant or lactating individuals
• Inability to provide consent for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEG	Blood transfusion	Blood transfusion
Prothrombin Time (PT)/International normalized ratio (INR)	Blood transfusion	Blood transfusion

Primary Outcome Measures

Name	Time	Method
Units of fresh frozen plasma (FFP) and platelet transfused	2 week	Will compare how much FFP and platelet transfusion patients receiving between 2 groups.