INR Comparison Testing in Cardiac Surgery

Coagulation Disorder Clinical Trial

Official title:

Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267823
• Other study ID #: 20170003
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: March 21, 2019

Study information

• Verified date: June 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigator is testing blood samples to compare the results of two different techniques. Since blood loss and the need for blood transfusions continue to be major problems after heart surgery and other types of surgery, the blood clotting levels are constantly checked during heart surgery as part of clinical care.The purpose of this study is to compare the INR levels in blood before and after the heart bypass during surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients greater than or equal to 18 years of age.

• Patients undergoing elective surgery.

• Patients undergoing cardiac surgery.

• Patients to undergo general anesthesia with endotracheal intubation.

• Patients with well-controlled health disorders.

Exclusion Criteria:

• Patients currently on Coumadin or other anticoagulants; including, direct thrombin inhibitors and direct Xa inhibitors.

• Patients who are under 18 years of age or pregnant.

• Patients undergoing emergency surgery.

• Patients with known coagulation disorders.

• Patients who are unable to provide informed consent in the form of a signature

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders

Intervention

Diagnostic Test:
• International Normal Ratio (INR)
Blood test for INR using laboratory and point of care methods

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in correlation between laboratory and point of care INR	Pearson's Coefficient	Baseline, Within ten minutes of completion of bypass
Secondary	Change in agreement between laboratory and point of care INR	Bland-Altman plots	Baseline, Within ten minutes of completion of bypass