Development of a ¡°two hit¡± in vivo autologous platelet transfusion model in healthy volunteers
- Conditions
- Transfusion related acute lung injury (TRALI), Metabolic recovery of transfused thrombocytes after storage
- Registration Number
- NL-OMON26852
- Lead Sponsor
- Academisch Medisch Centrum, Amsterdam, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
1)Healthy male volunteer
2)Age ¡Ý 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, DLCO measurement, chest x-ray).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Test the hypothesis that in the presence of a ¡°first hit¡± an aged apheresis platelet transfusion is able to induce a mild form of ALI.
- Secondary Outcome Measures
Name Time Method 1)unravel several hypothesized inflammatory processes in the lungs of patients that develop TRALI (i.e., production of inflammatory mediators, neutrophil activation, complement activation, disturbed alveolar fibrin turnover).<br /><br>2)assess the usefulness of several potential biomarkers of lung injury in TRALI (in particular recently proposed potential biomarkers, such as surfactant proteins, Clara cell protein, sRAGE and KL-6).<br /><br>3)identify phenotypic changes of the transfused platelets and their interaction with other cell types in the receiver¡¯s circulation and their potential contribution to the development of lung injury.<br /><br>4)Metabolic recovery of transfused thrombocytes after storage