CompletedPhase 4

Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Switzerland50 participantsStarted 2009-04

Plain-language summary

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

Who can participate

Age range25 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

maximum amplitude in thrombelastography

Timeframe: 1 hour

Trial details

NCT IDNCT01057420

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

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