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CompletedNCT02205827Updated May 20, 2020

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

An interventional study of Single-arm in Healthy, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.. Completed at 1 site in United States. 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. · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Healthy

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Keywords

  • whole blood clotting time
03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 12 is below the median of 106 across 849 interventional studies indexed under Thrombosis.

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Lead sponsor

Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • No intervention
    Single-arm

    healthy volunteers

    Other: Single-arm

Interventions

  • OtherSingle-arm

    collection of blood for assessment of whole blood clotting time

    Also known as: Whole Blood Clotting Time assessment

06

What researchers measure

Primary outcomes

  1. Variability in whole blood clotting time measurement

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

    Time frame: 1 day

07

Study locations

1 site
  • Quintiles Phase I Services, LLC
    Overland Park, Kansas 66211, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02205827
Lead sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Jul 31, 2014
Start date
Apr 2014
Primary completion
May 2014
Completion
May 2014
Last update
May 20, 2020

Study contacts

James Costin, MD
study director · Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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