An observational study in Healthy, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. · Observational
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.
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).
healthy volunteers
Exclusion Criteria:
Blood will be sampled by direct venipuncture on 8 occasions.
Other: Blood drawn by direct venipuncture · Drug: edoxaban · Drug: Enoxaparin · Drug: Saline sham
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.
Distribution and variability of WBCT measurements
Assessment of the analytical measurement range, reproducibility and precision of WBCT measurement in human blood spiked with predetermined concentrations of enoxparin and edoxaban
Time frame: 1 day
No study locations are listed for this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.