The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Cirrhosis, Coagulopathy Clinical Trial

Official title:

The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02990273
• Other study ID #: IRB00113092
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 19, 2021

Study information

• Verified date: January 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cirrhosis, Coagulopathy
• Hemostatic Disorders

Intervention

Biological:
• Blood transfusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Units of fresh frozen plasma (FFP) and platelet transfused	Will compare how much FFP and platelet transfusion patients receiving between 2 groups.	2 week