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OpenTrials
Completed

NCT Number: NCT01935284

Evaluation of Blood Gas Syringes

To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bionostics

Devens, Massachusetts, 01434, United States

About this study

This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years of age or older
  • Willing and able to independently sign an English Informed Consent
  • Have adequate veins for sampling blood from both right and left upper extremities

Exclusion criteria

  • Currently taking anti-coagulation medication
  • Have a known bloodborne disease or bleeding tendency
  • Have a known fear or adverse reaction to needles or blood
  • Women who are pregnant or nursing

Treatment and study plan

Primary outcomes

  1. Differences in analyte values obtained from three different blood gas syringes for each analyzer tested

    Time frame: Blood analysis within 30 minutes of draw

    For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer.

Sponsors and collaborators

Lead sponsor

Smiths Medical, ASD, Inc.

Industry

Collaborators

  • Bionostics

Registry information

Official study title

Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes

Acronym: Analyze ABS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2013
Registry last updated
Sep 5, 2013

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.