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OpenTrials
Completed

NCT Number: NCT03267823

INR Comparison Testing 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.

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Key information

Conditions

Coagulation Disorder Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami Hospital

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

International Normal Ratio (INR)

Diagnostic Test

Blood test for INR using laboratory and point of care methods

Primary outcomes

  1. Change in correlation between laboratory and point of care INR

    Time frame: Baseline, Within ten minutes of completion of bypass

    Pearson's Coefficient

Secondary outcomes

  1. Change in agreement between laboratory and point of care INR

    Time frame: Baseline, Within ten minutes of completion of bypass

    Bland-Altman plots

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2017
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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