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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

Tracking Information
First Submitted Date February 14, 2014
First Posted Date October 2, 2014
Last Update Posted Date October 2, 2014
Study Start Date October 2013
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2014)
The International Normalised Ratio (INR) will be measured by the laboratory assay and the Hemochron Signature Elite device. [ Time Frame: 18 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay
Official Title Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Micro Coagulation Instrument Compared With Laboratory Assay
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Blood Coagulation Tests
Intervention Not Provided
Study Groups/Cohorts Surgical Patient
These are the results from the blood samples taken from the study participants.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 29, 2014)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02255214
Other Study ID Numbers 2013/0300
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cameron Ferguson, NHS Lothian
Study Sponsor NHS Lothian
Collaborators Not Provided
Investigators
Principal Investigator: Cameron R Ferguson, MBChB MRCP NHS Lothian
PRS Account NHS Lothian
Verification Date September 2014