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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205827

Enrollment

Registered

2014-07-31

Start date

2014-04-30

Completion date

2014-05-31

Last updated

2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

whole blood clotting time

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.

Detailed description

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

Interventions

OTHERSingle-arm

collection of blood for assessment of whole blood clotting time

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026