INR Comparison Testing in Cardiac Surgery

NCT ID: NCT03267823

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-03-21

Brief Summary

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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

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Conditions

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Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart surgery

Patients undergoing heart surgery will have blood samples tested for INR values

International Normal Ratio (INR)

Intervention Type DIAGNOSTIC_TEST

Blood test for INR using laboratory and point of care methods

Interventions

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International Normal Ratio (INR)

Blood test for INR using laboratory and point of care methods

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Michael Fabbro

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Fabbro, DO

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Hospital

Miami, Florida, United States

Site Status

Countries

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United States

References

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Fabbro M 2nd, Abalo M, Fermin L, Andrews DM, Patel PA. Comparison of international normalized ratio determined by point-of-care to standard laboratory testing before and after reversal of heparin in cardiac surgery. Blood Coagul Fibrinolysis. 2020 Mar;31(2):140-144. doi: 10.1097/MBC.0000000000000889.

Reference Type DERIVED
PMID: 31934886 (View on PubMed)

Other Identifiers

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20170003

Identifier Type: -

Identifier Source: org_study_id

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