Trial Outcomes & Findings for Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay (NCT NCT02255214)
NCT ID: NCT02255214
Last Updated: 2026-01-30
Results Overview
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
COMPLETED
24 participants
18 months
2026-01-30
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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24
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data not collected
Baseline characteristics by cohort
| Measure |
Participant Group
n=24 Participants
Baseline characteristics for the participants were not recorded.
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|---|---|
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Age, Customized
Age not recorded
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0 Participants
Age data not collected
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Sex/Gender, Customized
Sex not recorded
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0 Participants
Sex/gender not recorded
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Region of Enrollment
United Kingdom
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24 participants
n=24 Participants
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PRIMARY outcome
Timeframe: 18 monthsThe 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
Outcome measures
| Measure |
Primary Outcome Measure Results
n=24 Participants
All participants
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|---|---|
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The International Normalised Ratio (INR) Will be Measured by the Laboratory Assay and the Hemochron Signature Elite Device.
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23 Participants
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Adverse Events
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place