INR Comparison Testing in Cardiac Surgery | NCT03267823

Studies
INR Comparison Testing in Cardiac Surgery

NCT03267823

Sponsor

University of Miami

Status

Completed

Last Update Posted

Jun 6, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Coagulation Disorder

Interventions

International Normal Ratio (INR)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Mar 21, 2019Actual

Completion Date

Mar 21, 2019Actual

First Submitted Date

Aug 24, 2017

First Submission Date that Met QC Criteria

Aug 29, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2019

Last Update Posted Date

Jun 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Heart surgery		Patients undergoing heart surgery will have blood samples tested for INR values	Diagnostic Test: International Normal Ratio (INR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
International Normal Ratio (INR)	Diagnostic Test	Blood test for INR using laboratory and point of care methods	Heart surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in correlation between laboratory and point of care INR	Pearson's Coefficient	Baseline, Within ten minutes of completion of bypass

Secondary Outcomes

Measure	Description	Time Frame
Change in agreement between laboratory and point of care INR	Bland-Altman plots	Baseline, Within ten minutes of completion of bypass

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Fabbro, DO	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami Hospital		Miami	Florida	33136	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31934886	Derived	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.

ID	Term
D020141	Hemostatic Disorders
D006470	Hemorrhage
D013927	Thrombosis

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases