Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-02-28

Brief Summary

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The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.

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Detailed Description

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Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant).

Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood Sample

Blood will be sampled by direct venipuncture on 8 occasions.

Blood drawn by direct venipuncture

Intervention Type OTHER

Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.

edoxaban

Intervention Type DRUG

Enoxaparin

Intervention Type DRUG

Saline sham

Intervention Type DRUG

Interventions

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Blood drawn by direct venipuncture

Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.

Intervention Type OTHER

edoxaban

Intervention Type DRUG

Enoxaparin

Intervention Type DRUG

Saline sham

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed and dated informed consent form
2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -

Exclusion Criteria

1. Subjects who cannot communicate reliably with the Investigator
2. History of major bleeding or major trauma within the 6 months prior to signing informed consent
3. Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids)
4. Significant infection or known inflammatory process in the 2 weeks prior to screening
5. Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent
6. Treatment with any investigation product or therapy within 30 days prior to screening
7. Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling
8. Unwilling to comply with the procedures in the protocol
9. Currently enrolled in any other study -

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes