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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03267823
Other study ID # 20170003
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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