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INR Comparison Testing in Cardiac Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03267823
Enrollment
50
Registered
2017-08-30
Start date
2017-10-01
Completion date
2019-03-21
Last updated
2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder

Keywords

Bleeding, heart surgery, coagulation, coagulopathy, INR

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.

Interventions

DIAGNOSTIC_TESTInternational Normal Ratio (INR)

Blood test for INR using laboratory and point of care methods

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in correlation between laboratory and point of care INRBaseline, Within ten minutes of completion of bypassPearson's Coefficient

Secondary

MeasureTime frameDescription
Change in agreement between laboratory and point of care INRBaseline, Within ten minutes of completion of bypassBland-Altman plots

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026