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...
Brief Summary
Official Title: “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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
- Study Primary Completion Date: March 2010
Intervention(s) in this Clinical Trial
- Drug: oxygen inhalation
- Inhalation of 80% oxygen via face mask
Arms, Groups and Cohorts in this Clinical Trial
- Other: Inhalation of 80% Oxygen
- Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours
Outcome Measures for this Clinical Trial
Primary Measures
- maximum amplitude in thrombelastography
- Time Frame: 1 hour
Safety Issue?: No
- Time Frame: 1 hour
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 25 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: University of Zurich Other
Overall Clinical Trial Officials and Contacts
Johannes Wacker, MD Principal Investigator Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01057420
Study ID Number: O2Tc-2009
ClinicalTrials.gov Identifier: NCT01057420
Health Authority: Switzerland: Ethikkommission
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01057420
