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

NCT03296982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2020-05-20

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

OTHER

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.

DRUG

edoxaban

DRUG

Enoxaparin

DRUG

Saline sham

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Rasmussen, MD · Quintiles Phase 1 Services, LLC Overland Park KS

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-02-28
Completion
2015-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296982 on ClinicalTrials.gov