Coagulation DisorderNCT03267823
INR Comparison Testing in Cardiac Surgery
An observational study of Coagulation Disorder, run by University of Miami at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- International Normal Ratio (INR)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 21 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coagulation Disorder
- Being tested
- International Normal Ratio (INR)
- Keywords
- Bleeding, heart surgery, coagulation, coagulopathy, INR
- Medical subject headings
- Hemostatic Disorders, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
International Normal Ratio (INR)Diagnostic test
Blood test for INR using laboratory and point of care methods
| Study group | Role | What they receive |
|---|---|---|
| Heart surgery | Patients undergoing heart surgery will have blood samples tested for INR values Receives: Diagnostic Test: International Normal Ratio (INR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in correlation between laboratory and point of care INR
Pearson's Coefficient
Measured: Baseline, Within ten minutes of completion of bypass
Secondary outcomes (1)
Change in agreement between laboratory and point of care INR
Bland-Altman plots
Measured: Baseline, Within ten minutes of completion of bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Oct 2017
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fabbro, University of Miami
- Investigators
- Michael Fabbro, DO, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267823
- Sponsor's protocol ID
- 20170003
- Status last verified
- Jun 2019
- First submitted
- 24 Aug 2017
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31934886
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03267823
- Acronym / sponsor ID
- 20170003
- Conditions
- Coagulation Disorder
- Keywords
- Bleeding, heart surgery, coagulation, coagulopathy, INR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart surgery | – | Diagnostic Test: International Normal Ratio (INR)Patients undergoing heart surgery will have blood samples tested for INR values |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| International Normal Ratio (INR)Blood test for INR using laboratory and point of care methods | Diagnostic test | Heart surgery |
Primary outcome
Change in correlation between laboratory and point of care INR
Time frame: Baseline, Within ten minutes of completion of bypass
Pearson's Coefficient
1 secondary outcome
Change in agreement between laboratory and point of care INR
Time frame: Baseline, Within ten minutes of completion of bypass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 31934886Fabbro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fabbro, DO principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation Disorder, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in correlation between laboratory and point of care INR (time frame: Baseline, Within ten minutes of completion of bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.