Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Inhalation of 80% Oxygen

Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours

Group Type OTHER

oxygen inhalation

Intervention Type DRUG

Inhalation of 80% oxygen via face mask

Interventions

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oxygen inhalation

Inhalation of 80% oxygen via face mask

Intervention Type DRUG

Eligibility Criteria

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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.

* allergy or incompatibility to substances/materials applied in the study;
* very thin veins/arteries.

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes