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Completed

NCT Number: NCT02207205

Variability in the Measurement of 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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Clinical Research Unit

Durham, North Carolina, 27710, United States

About this study

No investigational products were administered to any subjects.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood drawn from indwelling catheters versus direct venipuncture

Drug

Evaluation of the source of blood samples on whole blood clotting time

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

Industry

Collaborators

  • Duke Clinical Research Institute

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 4, 2014
Registry last updated
Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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