The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

NCT02990273 | Terminated

• 1 other identifier: IRB00113092
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis, Coagulopathy

Outcome Measures

Primary Outcomes (1)

• Units of fresh frozen plasma (FFP) and platelet transfused

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

  2 week

Study Arms (2)

TEG

ACTIVE COMPARATOR

Blood transfusion

Biological: Blood transfusion

Prothrombin Time (PT)/International normalized ratio (INR)

ACTIVE COMPARATOR

Blood transfusion

Biological: Blood transfusion

Interventions

Blood transfusion BIOLOGICAL

Prothrombin Time (PT)/International normalized ratio (INR); TEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Fibrosis; Hemostatic Disorders

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Tinsay Woreta

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: December 13, 2016
• Study Start: January 1, 2017
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01