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
  Purpose

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

Condition Intervention Phase
Healthy Volunteers
Drug: oxygen inhalation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • maximum amplitude in thrombelastography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Inhalation of 80% Oxygen
Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours
Drug: oxygen inhalation
Inhalation of 80% oxygen via face mask

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057420

Locations
Switzerland
Surgical Intensive Care Medicine
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Johannes Wacker, MD Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich
Study Director: Reto Stocker, Prof., MD Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
  More Information

No publications provided

Responsible Party: Johannes Wacker, MD, Surgical Intensive Care Medicine, UniversitaetsSpital Zurich
ClinicalTrials.gov Identifier: NCT01057420     History of Changes
Other Study ID Numbers: O2Tc-2009
Study First Received: January 25, 2010
Last Updated: August 23, 2010
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on October 21, 2014