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Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay

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ClinicalTrials.gov Identifier: NCT02255214
Recruitment Status : Unknown
Verified September 2014 by Cameron Ferguson, NHS Lothian.
Recruitment status was:  Recruiting
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Cameron Ferguson, NHS Lothian

Brief Summary:

Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages over a general anaesthetic however contraindications include coagulopathy. Guidelines suggest a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5 or greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of its effects is required.

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.


Condition or disease
Blood Coagulation Tests

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Micro Coagulation Instrument Compared With Laboratory Assay
Study Start Date : October 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Group/Cohort
Surgical Patient
These are the results from the blood samples taken from the study participants.



Primary Outcome Measures :
  1. The International Normalised Ratio (INR) will be measured by the laboratory assay and the Hemochron Signature Elite device. [ Time Frame: 18 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include all adult patients presenting for elective surgery who have stopped their warfarin therapy within the last 7 days. They will be approached in the Day Surgery Unit and Day of Surgery Assessment unit within a single centre.
Criteria

Inclusion Criteria:

  • Adult patients presenting for elective surgery who have stopped their warfarin therapy within the last 7 days.

Exclusion Criteria:

  • Adults with incapacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255214


Contacts
Contact: Cameron R Ferguson, MBChB MRCP cameronferguson@nhs.net
Contact: Gary Morrison, MBChB FRCA gary.morrison@nhslothian.scot.nhs.uk

Locations
United Kingdom
Royal Infirmary Edinburgh Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
Contact: Karen Maitland       karen.maitland@nhslothian.scot.nhs.uk   
Sponsors and Collaborators
NHS Lothian
Investigators
Principal Investigator: Cameron R Ferguson, MBChB MRCP NHS Lothian

Responsible Party: Cameron Ferguson, Dr Cameron Ferguson, NHS Lothian
ClinicalTrials.gov Identifier: NCT02255214     History of Changes
Other Study ID Numbers: 2013/0300
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014