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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Single-arm


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Single-arm<br>healthy volunteers | Other: Single-arm<br>* collection of blood for assessment of whole blood clotting time<br>* Other names: Whole Blood Clotting Time assessment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
whole blood clotting time