INR Comparison Testing in Cardiac Surgery

Completed

• Conditions: Coagulation Disorder
• Interventions: Diagnostic Test: International Normal Ratio (INR)

• Registration Number: NCT03267823
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Study Start: 2017-10-01
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart surgery	International Normal Ratio (INR)	Patients undergoing heart surgery will have blood samples tested for INR values

Primary Outcome Measures

Name	Time	Method
Change in correlation between laboratory and point of care INR	Baseline, Within ten minutes of completion of bypass	Pearson's Coefficient

Secondary Outcome Measures

Name	Time	Method
Change in agreement between laboratory and point of care INR	Baseline, Within ten minutes of completion of bypass	Bland-Altman plots

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States