INR Comparison Testing in Cardiac Surgery

June 5, 2019 updated by: Michael Fabbro, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective cardiac surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart surgery
Patients undergoing heart surgery will have blood samples tested for INR values
Diagnostic test: International Normal Ratio (INR)
Blood test for INR using laboratory and point of care methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in correlation between laboratory and point of care INR
Time Frame: Baseline, Within ten minutes of completion of bypass
Pearson's Coefficient
Baseline, Within ten minutes of completion of bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in agreement between laboratory and point of care INR
Time Frame: Baseline, Within ten minutes of completion of bypass
Bland-Altman plots
Baseline, Within ten minutes of completion of bypass

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

March 21, 2019

Study Completion (ACTUAL)

March 21, 2019

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (ACTUAL)

August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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