- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, CH-8091
- Surgical Intensive Care Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Inhalation of 80% Oxygen
Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours
|
Inhalation of 80% oxygen via face mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maximum amplitude in thrombelastography
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johannes Wacker, MD, Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich
- Study Director: Reto Stocker, Prof., MD, Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- O2Tc-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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