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Clinical Trials/NCT02207205
NCT02207205CompletedNot Applicable

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

Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.1 site in 1 country10 target enrollmentStarted: April 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Catheter vs venipuncture blood samples

Other

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

Intervention: Blood drawn from indwelling catheters versus direct venipuncture (Drug)

Outcomes

Primary Outcomes

Whole blood clotting time results from blood drawn from indwelling catheters and direct venipuncture

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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Variability in the Measurement of WBCT... | Clinical Trial