INR Comparison Testing in Cardiac Surgery
Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2019
CompletedJune 6, 2019
June 1, 2019
1.5 years
August 24, 2017
June 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in correlation between laboratory and point of care INR
Pearson's Coefficient
Baseline, Within ten minutes of completion of bypass
Secondary Outcomes (1)
Change in agreement between laboratory and point of care INR
Baseline, Within ten minutes of completion of bypass
Study Arms (1)
Heart surgery
Patients undergoing heart surgery will have blood samples tested for INR values
Interventions
Blood test for INR using laboratory and point of care methods
Eligibility Criteria
Patients undergoing elective cardiac surgery
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Hospital
Miami, Florida, 33136, United States
Related Publications (1)
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.
PMID: 31934886DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Fabbro, DO
University of Miami
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 30, 2017
Study Start
October 1, 2017
Primary Completion
March 21, 2019
Study Completion
March 21, 2019
Last Updated
June 6, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share