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

Completed

• Conditions: Healthy
• Interventions: Other: Blood drawn by direct venipuncture; Drug: edoxaban; Drug: Enoxaparin; Drug: Saline sham

• Registration Number: NCT03296982
• Lead Sponsor: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-18
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-29
• Status Verified: 2017-11
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blood Sample	Saline sham	Blood will be sampled by direct venipuncture on 8 occasions.
Blood Sample	Blood drawn by direct venipuncture	Blood will be sampled by direct venipuncture on 8 occasions.
Blood Sample	Enoxaparin	Blood will be sampled by direct venipuncture on 8 occasions.
Blood Sample	edoxaban	Blood will be sampled by direct venipuncture on 8 occasions.

Primary Outcome Measures

Name	Time	Method
Distribution and variability of WBCT measurements	1 day	Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban