Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01057420
First received: January 25, 2010
Last updated: August 23, 2010
Last verified: August 2010

January 25, 2010
August 23, 2010
April 2009
March 2010   (final data collection date for primary outcome measure)
maximum amplitude in thrombelastography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057420 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Hyperoxemia on Platelet Function in Healthy Volunteers
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy Volunteers
Drug: oxygen inhalation
Inhalation of 80% oxygen via face mask
Inhalation of 80% Oxygen
Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours
Intervention: Drug: oxygen inhalation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
25 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01057420
O2Tc-2009
No
Johannes Wacker, MD, Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
University of Zurich
Not Provided
Principal Investigator: Johannes Wacker, MD Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich
Study Director: Reto Stocker, Prof., MD Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
University of Zurich
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP