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Completed

NCT Number: NCT01057420

Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Prospective, controlled, randomized crossover volunteer study to investigate the effect of hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on blood coagulation, especially platelet function, as measured by thrombelastography. According to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by means of reactive oxygen species. This study aims at investigating a possible pro-coagulant effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are integrated.

* Trial with medical device

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Key information

Conditions

Healthy Volunteers

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Surgical Intensive Care Medicine

Zurich, CH-8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • informed consent; no coagulation disorder or other illnesses;
  • non-smoker;
  • women: no pharmacological contraception, negative pregnancy test;
  • 25-45 years old; no medication; no acute or chronic airway problems;
  • for 24 hours before study: no extreme physical activity, no polyphenol-containing food (red wine, apples, cabbage, garlic);
  • for 48 hours: no caffeine-containing drinks, no dark chocolate.

Exclusion criteria

  • Lack of one of the inclusion criteria;
  • allergy or incompatibility to substances/materials applied in the study;
  • very thin veins/arteries.

Treatment and study plan

oxygen inhalation

Drug

Inhalation of 80% oxygen via face mask

Primary outcomes

  1. maximum amplitude in thrombelastography

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2010
Registry last updated
Aug 24, 2010

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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