Transfusion model in healthy volunteers
Completed
- Conditions
- Transfusion related acute lung injuryHealthy VolunteersStorage Transfusion
- Registration Number
- NL-OMON27952
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1. Healthy male volunteer
2. Age ≥ 18 years <35 years
Exclusion Criteria
1. No informed consent
2. Any abnormal test result during the screening prior to inclusion of the study (medical history, physical examination, ECG, blood and urine examination, spirometry, chest x-ray).
3. History of drugs abuse
4. Any present medication use on prescription
5. Smoking < 6 months
6. History of blood donation < 3 months
7. Previously transfused
8. Participation in any other medical study < 3 months
9. Participated in previous volunteer studies using LPS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Onset of lung injury measured by laboratory measurements, functional assays, radiological imaging, pulmonary function tests.
- Secondary Outcome Measures
Name Time Method 1. Markers of inflammation and coagulation <br>2. Identification of potential bio-markers for diagnosing TRALI<br>