The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02990273
• Collaborator: (none)
• Enrollment: 1
• Arms: 2
• Actual Duration (Months): 48.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Coagulopathy	Biological: Blood transfusion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jan 19, 2021
• Actual Study Completion Date: Jan 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TEG Blood transfusion	Biological: Blood transfusion
Active Comparator: Prothrombin Time (PT)/International normalized ratio (INR) Blood transfusion	Biological: Blood transfusion

Outcome Measures

Primary Outcome Measures

1. Units of fresh frozen plasma (FFP) and platelet transfused [2 week]

   Will compare how much FFP and platelet transfusion patients receiving between 2 groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Tinsay Woreta, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02990273
• Other Study ID Numbers: IRB00113092
• First Posted: Dec 13, 2016
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Jan 22, 2021