Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057420
• Other study ID #: O2Tc-2009
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: August 23, 2010
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2010
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• oxygen inhalation
Inhalation of 80% oxygen via face mask

Locations

Country	Name	City	State
Switzerland	Surgical Intensive Care Medicine	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum amplitude in thrombelastography		1 hour	No