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

Healthy Clinical Trial

Official title:
A Study to Determine the Inter/Intra Observer and Intra-Subject Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03296982
Study type Observational
Source AMAG Pharmaceuticals, Inc.
Contact
Status Completed
Phase
Start date December 2014
Completion date February 2015
View Details
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