INR Comparison Testing in Cardiac Surgery

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03267823
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coagulation Disorder	Diagnostic Test: International Normal Ratio (INR)

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Mar 21, 2019
• Actual Study Completion Date: Mar 21, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Change in correlation between laboratory and point of care INR [Baseline, Within ten minutes of completion of bypass]

   Pearson's Coefficient

Secondary Outcome Measures

1. Change in agreement between laboratory and point of care INR [Baseline, Within ten minutes of completion of bypass]

   Bland-Altman plots

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Michael Fabbro, DO, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Fabbro, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03267823
• Other Study ID Numbers: 20170003
• First Posted: Aug 30, 2017
• Last Update Posted: Jun 6, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Fabbro, Assistant Professor, University of Miami: Bleeding; heart surgery; coagulation; coagulopathy; INR
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Jun 6, 2019