Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Phase 4

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: oxygen inhalation

• Registration Number: NCT01057420
• Lead Sponsor: University of Zurich

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhalation of 80% Oxygen	oxygen inhalation	Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours

Primary Outcome Measures

Name	Time	Method
maximum amplitude in thrombelastography	1 hour

Trial Locations

Locations (1)

Surgical Intensive Care Medicine; 🇨🇭 Zurich, Switzerland