Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|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|
These are the results from the blood samples taken from the study participants.
- The International Normalised Ratio (INR) will be measured by the laboratory assay and the Hemochron Signature Elite device. [ Time Frame: 18 months ]
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
|Contact: Cameron R Ferguson, MBChB MRCPfirstname.lastname@example.org|
|Contact: Gary Morrison, MBChB FRCAemail@example.com|
|Royal Infirmary Edinburgh||Recruiting|
|Edinburgh, Lothian, United Kingdom, EH16 4SA|
|Contact: Karen Maitland firstname.lastname@example.org|
|Principal Investigator:||Cameron R Ferguson, MBChB MRCP||NHS Lothian|