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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:4/17/2018
Start Date:April 2014
End Date:June 2014

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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

1. Determine if there is any difference between the whole blood clotting time results
obtained from blood drawn from indwelling catheters and direct venipuncture

2. Determine the intra-subject variability in both procedures

No investigational products were administered to any subjects.

Inclusion Criteria:

1. Signed and dated, written informed consent (Institutional Review Board [IRB]-approved
informed consent form [ICF]).

2. Healthy (as determined by medical history) male and female subjects aged 18 to 65
years (inclusive) with suitable veins for venipuncture.

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 drug (NSAID) or medications (including
aspirin) 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.
We found this trial at
1
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Durham, North Carolina 27710
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Durham, NC
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