Development of a *two hit* in vivo autologous transfusion model in healthy volunteers
Completed
- Conditions
- transfusie gerelateerde longschadeacute hypoxia after blood transfusion
- Registration Number
- NL-OMON39642
- Lead Sponsor
- Academisch Medisch Centrum
- 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 <p>A significant increase (p<0.05, ANOVA multiple comparison test) in total<br /><br>protein leakage in the BAL-fluid of the subjects receiving a *first hit* of LPS<br /><br>and one unit of RBCs stored for 35 days compared to controls. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. A significant increase (p<0.05, ANOVA multiple comparison test) in<br /><br>inflammation and coagulation markers in the BAL-fluid and plasma samples of the<br /><br>subjects receiving a *first hit* of LPS and one unit of RBCs stored for 35 days<br /><br>compared to controls.<br /><br>2. Identification of potential bio-markers for diagnosing TRALI<br /><br>3. Identification of phenotypic changes of the transfused red blood cells,<br /><br>their interaction with other cell types in the receiver*s circulation and their<br /><br>potential contribution to the development of lung injury.</p><br>