Healthy VolunteersPhase 4NCT01057420
Effect of Hyperoxemia on Platelet Function in Healthy Volunteers
A Phase 4 study testing oxygen inhalation in people with Healthy Volunteers, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- oxygen inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2009to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Lack of one of the inclusion criteria;
- allergy or incompatibility to substances/materials applied in the study;
- very thin veins/arteries.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Healthy Volunteers
- Being tested
- oxygen inhalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen inhalationDrug
Inhalation of 80% oxygen via face mask
| Study group | Role | What they receive |
|---|---|---|
| Inhalation of 80% Oxygen | Other | Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours Receives: Drug: oxygen inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum amplitude in thrombelastography
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Johannes Wacker, MD, Principal investigator, Surgical Intensive Care Medicine, UniversitaetsSpital ZuerichReto Stocker, Prof., MD, Study director, Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057420
- Sponsor's protocol ID
- O2Tc-2009
- Status last verified
- Aug 2010
- First submitted
- 25 Jan 2010
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperoxemia on Platelet Function in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01057420
- Acronym / sponsor ID
- O2Tc-2009
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhalation of 80% Oxygen | Other | Drug: oxygen inhalationInhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (3 listed)
- Lack of one of the inclusion criteria;
- allergy or incompatibility to substances/materials applied in the study;
- very thin veins/arteries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen inhalationInhalation of 80% oxygen via face mask | Drug | Inhalation of 80% Oxygen |
Primary outcome
maximum amplitude in thrombelastography
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2010.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Wacker, MD principal investigator
Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich
Reto Stocker, Prof., MD study director
Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxygen inhalation in people with Healthy Volunteers, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum amplitude in thrombelastography (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2010.