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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Patient | These are the results from the blood samples taken from the study participants. |
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| Measure | Description | Time Frame |
|---|---|---|
| The International Normalised Ratio (INR) Will be Measured by the Laboratory Assay and the Hemochron Signature Elite Device. | The correlation between the international normalised ratio measured by the laboratory assay and the Hemochron Signature Elite device was assessed.Number of participants with a higher INR measurement by the Hemochron Signature Elite device than laboratory assay | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Cameron R Ferguson, MBChB MRCP | NHS Lothian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary Edinburgh | Edinburgh | Lothian | EH16 4SA | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | The patients were collected as one group. Baseline characteristics were not obtained for this study as per the protocol. Each patient had one sample of blood taken, as per the study protocol. This blood sample was used for both the point of care coagulation testing device, and the laboratory coagulation test. No further intervention was taken place on any patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participant Group | Baseline characteristics for the participants were not recorded. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age data not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The International Normalised Ratio (INR) Will be Measured by the Laboratory Assay and the Hemochron Signature Elite Device. | The correlation between the international normalised ratio measured by the laboratory assay and the Hemochron Signature Elite device was assessed.Number of participants with a higher INR measurement by the Hemochron Signature Elite device than laboratory assay | Posted | Count of Participants | Participants | 18 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events | There were no adverse events encountered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cameron Ferguson | NHS Lothian | 0131 536 1000 | cameronferguson@nhs.net |
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| Participants |
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| Sex/Gender, Customized | Sex/gender not recorded | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 24 |
| 0 |
| 24 |
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