Clincosm LogoSign in Get a demo

A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements

Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02205827
Collaborator
Quintiles, Inc. (Industry)
12
Enrollment
1
Location
1
Arm
30
Duration (Days)
12.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.

Condition or Disease Intervention/Treatment Phase
  • Other: Single-arm
 N/A

Detailed Description

No investigational product was administered to any subject in this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Single-arm

healthy volunteers

Other: Single-arm
collection of blood for assessment of whole blood clotting time
Other Names:
  • Whole Blood Clotting Time assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Variability in whole blood clotting time measurement [1 day]

      Assessment of variability in whole blood clotting time measurements in human blood collected from volunteers in across five technicians

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).

    2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)

    Exclusion Criteria:

    1. Healthy subjects who do not conform to the above inclusion criteria.

    2. Healthy subjects who cannot communicate reliably with the Investigator.

    3. History of major bleeding or major trauma within the past 6 months

    4. 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).

    5. Significant infection or known inflammatory process within 2 weeks of screening.

    6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.

    7. 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

    8. Unwillingness or inability to comply with procedures required in this protocol.

    9. Subjects who are concurrently enrolled in any other clinical study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Quintiles Phase I Services, LLC Overland Park Kansas United States 66211

    Sponsors and Collaborators

    • Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
    • Quintiles, Inc.

    Investigators

    • Study Director: James Costin, MD, Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02205827
    Other Study ID Numbers:
    • PER977-01-005
    First Posted:
    Jul 31, 2014
    Last Update Posted:
    May 20, 2020
    Last Verified:
    Jul 1, 2014
    Keywords provided by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
    whole blood clotting time
    Additional relevant MeSH terms:
    Thrombosis

    Study Results

    No Results Posted as of May 20, 2020