Status:
COMPLETED
Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
Lead Sponsor:
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
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 ...
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 f...
Eligibility Criteria
Inclusion
- Signed and dated informed consent form
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -
Exclusion
- Subjects who cannot communicate reliably with the Investigator
- History of major bleeding or major trauma within the 6 months prior to signing informed consent
- Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids)
- Significant infection or known inflammatory process in the 2 weeks prior to screening
- Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent
- Treatment with any investigation product or therapy within 30 days prior to screening
- Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling
- Unwilling to comply with the procedures in the protocol
- Currently enrolled in any other study -
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03296982
Start Date
December 1 2014
End Date
February 1 2015
Last Update
May 20 2020
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