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

Perosphere Pharmaceuticals

Status

Completed

Conditions

Healthy

Treatments

Other: Single-arm

Study type

Interventional

Funder types

Industry

Identifiers

NCT02205827

PER977-01-005

Details and patient eligibility

About

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.

Full description

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

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Exclusion criteria

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