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

NCT02205827 | Completed

• 1 other identifier: PER977-01-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

whole blood clotting time

Outcome Measures

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

  1 day

Study Arms (1)

Single-arm

NO INTERVENTION

healthy volunteers

Other: Single-arm

Interventions

Single-arm OTHER

collection of blood for assessment of whole blood clotting time

Also known as: Whole Blood Clotting Time assessment

Single-arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 (NSAID) or medications (including any type of anticoagulant or aspirin \[ASA\]) 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.

Sponsors & Collaborators

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

Study Sites (1)

Quintiles Phase I Services, LLC

Overland Park, Kansas, 66211, United States

Location

Study Officials

• James Costin, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 31, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2020

Record last verified: 2014-07

Locations

US (1)