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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Blood drawn from indwelling catheters versus direct venipuncture

• Registration Number: NCT02207205
• Lead Sponsor: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

No investigational products were administered to any subjects.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-08-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Catheter vs venipuncture blood samples	Blood drawn from indwelling catheters versus direct venipuncture	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

Primary Outcome Measures

Name	Time	Method
Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture	single day sampling	Comparison of results in whole blood clotting time from blood sampled by direct venipuncture and from indwelling catheters as assessed by multiple technicians

Trial Locations

Locations (1)

Duke Clinical Research Unit; 🇺🇸 Durham, North Carolina, United States