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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205827
• Other study ID #: PER977-01-005
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Thrombosis

Intervention

Other:
• Single-arm
collection of blood for assessment of whole blood clotting time

Locations

Country	Name	City	State
United States	Quintiles Phase I Services, LLC	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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