Development of a *two hit* in vivo autologous platelet transfusion model in healthy volunteers

Recruiting

• Conditions: thrombocyte transfusion induced hypoxia; acute hypoxia after platelet blood transfusion; 10038716

• Registration Number: NL-OMON55634
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1. Male sex
2. Age 18-35 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).
3. History of drugs or alcohol abuse
4. Any present medication use on prescription
5. Smoking < 6 months
6. History of blood donation < 3 months
7. Blood loss of more 500 ml < 3 months
8. Previously transfused
9. Participation in any other medical drug study < 3 months
10. Participation in previous volunteer studies using LPS
11. Allergy or hypersensitivity for iodine
12. Active thyroid disease

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 PLTs stored for 7 days compared to controls.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. to unravel the several hypothesized inflammatory processes in the lungs of<br /><br>patients that develop TRALI (i.e., production of inflammatory mediators,<br /><br>neutrophil activation, complement activation, disturbed alveolar fibrin<br /><br>turnover).<br /><br>2. to assess the usefulness of several potential biomarkers of lung injury in<br /><br>TRALI (in particular recently proposed potential biomarkers, such as surfactant<br /><br>proteins, Clara cell protein, sRAGE and KL-6).<br /><br>3. to identify phenotypic changes of the transfused platelets and their<br /><br>interaction with other cell types in the receiver*s circulation and their<br /><br>potential contribution to the development of lung injury.<br /><br>4. Study the neurovascular coupling mechanism during endotoxemia</p><br>