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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55634

Enrollment

Registered

2014-11-18

Start date

2017-05-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thrombocyte transfusion induced hypoxia

Interventions

Methods: All subjects will be screened (medical history, physical examination, ECG, blood examination, spirometry, DLCO, chest x-ray) by the research physician of our hospital and of Sanquin Blood B

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Male sex 2. Age 18-35 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
A significant increase (p	—

Secondary

Measure	Time frame
1. to unravel the 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). 2. to 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). 3. to 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. 4. Study the neurovascular coupling mechanism during endotoxemia	—

Measure

Time frame

1. to unravel the 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). 2. to 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). 3. to 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. 4. Study the neurovascular coupling mechanism during endotoxemia

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026

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