Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture

Study Overview
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Brief Summary
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Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture Determine the intra-subject variability in both procedures

Detailed Description
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No investigational products were administered to any subjects.

Official Title
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A Study to Determine Variability in the Measurement of Whole Blood Clotting Time (WBCT) Between Blood Drawn From Indwelling Catheters and Direct Venipuncture

Conditions
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Healthy

Intervention / Treatment
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* Drug: Blood drawn from indwelling catheters versus direct venipuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]). Healthy (as determined by medical history) male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. 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 drug (NSAID) or medications (including aspirin) 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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Catheter vs venipuncture blood samples<br>Evaluation of whether there is any difference in results of whole blood clotting time in blood samples drawn from an indwelling catheter versus direct venipuncture | Drug: Blood drawn from indwelling catheters versus direct venipuncture<br>* Evaluation of the source of blood samples on whole blood clotting time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture | Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians | single day sampling |