Status:
COMPLETED
Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
Lead Sponsor:
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Collaborating Sponsors:
Duke Clinical Research Institute
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture 2. Determine the intra-subject variabi...
Detailed Description
No investigational products were administered to any subjects.
Eligibility Criteria
Inclusion
- Signed and dated, written informed consent (Institutional Review Board \[IRB\]-approved informed consent form \[ICF\]).
- Healthy (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture.
Exclusion
- Healthy subjects who do not conform to the above inclusion criteria.
- Healthy subjects who cannot communicate reliably with the Investigator.
- History of major bleeding or major trauma within the past 6 months
- Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
- Significant infection or known inflammatory process within 2 weeks of screening.
- Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
- Received non-steroidal anti-inflammatory drug (NSAID) or medications (including aspirin) with a direct effect on hemostasis within 7 days of testing
- Unwillingness or inability to comply with procedures required in this protocol.
- Subjects who are concurrently enrolled in any other clinical study.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02207205
Start Date
April 1 2014
End Date
June 1 2014
Last Update
April 4 2018
Active Locations (1)
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1
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710