A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
- Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
Exclusion Criteria
- Unwillingness or inability to comply with procedures required in this protocol.
- Healthy subjects who do not conform to the above inclusion criteria.
- 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).
- ...
- Unwillingness or inability to comply with procedures required in this protocol.
- Healthy subjects who do not conform to the above inclusion criteria.
- 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).
- Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
- 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.
- History of major bleeding or major trauma within the past 6 months
- Healthy subjects who cannot communicate reliably with the Investigator.
- Subjects who are concurrently enrolled in any other clinical study.
Summary
- Conditions
- Healthy
- Type
- Interventional
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
No investigational product was administered to any subject in this study.
No investigational product was administered to any subject in this study.
Inclusion Criteria
- Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
- Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
- Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)
Exclusion Criteria
- Unwillingness or inability to comply with procedures required in this protocol.
- Healthy subjects who do not conform to the above inclusion criteria.
- 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).
- ...
- Unwillingness or inability to comply with procedures required in this protocol.
- Healthy subjects who do not conform to the above inclusion criteria.
- 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).
- Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
- 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.
- History of major bleeding or major trauma within the past 6 months
- Healthy subjects who cannot communicate reliably with the Investigator.
- Subjects who are concurrently enrolled in any other clinical study.
Tracking Information
- NCT #
- NCT02205827
- Collaborators
- Quintiles, Inc.
- Investigators
- Study Director: James Costin, MD Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
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