Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay
NCT ID: NCT02255214
Last Updated: 2014-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2013-10-31
2015-05-31
Brief Summary
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The Hemochron Signature Elite is a portable micro coagulation system that can be used as a point of care (POC) anticoagulation monitoring device. Marketing is focussed on its accuracy, convenience and efficiency in delivering a coagulation result.
This study will assess the accuracy of this device in calculating the International Normalised Ratio (INR) result. This will be compared to another INR result obtained on the same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh (RIE) laboratories.
The study will include patients presenting for surgery who have had their warfarin therapy stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are currently identified in preoperative assessment clinics, on average 12 weeks prior to their date of surgery.
Anecdotally there appears to be a difference between the 'expected' and actual INR when a POC device is used. Concern exists that patients may be inappropriately denied the potential benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or conversely the investigators may be proceeding with CNB in patients with an unacceptably high INR if POC provides a falsely low result. There is also the possibility of improving hospital efficiency using this device as it provides a result much faster than the laboratory.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgical Patient
These are the results from the blood samples taken from the study participants.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
Responsible Party
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Cameron Ferguson
Dr Cameron Ferguson
Principal Investigators
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Cameron R Ferguson, MBChB MRCP
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Locations
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Royal Infirmary Edinburgh
Edinburgh, Lothian, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2013/0300
Identifier Type: -
Identifier Source: org_study_id
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