Blood Coagulation Tests Clinical Trial
Official title:
Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Micro Coagulation Instrument Compared With Laboratory Assay
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03647254 -
Efficacy of a Didactic Intervention in Anticoagulated Patients (TAOPE Study)
|
N/A | |
| Completed |
NCT01588327 -
A Prospective Pharmacodynamic Study of Dabigatran
|
N/A | |
| Completed |
NCT03280368 -
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
|
||
| Recruiting |
NCT01167660 -
Non Invasive Measurement of Coagulation in Term and Preterm Neonates
|
N/A | |
| Terminated |
NCT02839434 -
Evaluation of the Interference of Antithrombotic Agents With Laboratory Monitoring of Heparin Therapy
|