No registrations found.
ID
Source
Brief title
Health condition
Transfusion related acute lung injury
Healthy Volunteers
Storage
Transfusion
Sponsors and support
Intervention
Outcome measures
Primary outcome
Onset of lung injury measured by laboratory measurements, functional assays, radiological imaging, pulmonary function tests.
Secondary outcome
1. Markers of inflammation and coagulation
2. Identification of potential bio-markers for diagnosing TRALI
Background summary
Objective:
To investigate whether LPS-primed neutrophils can be activated by stored red blood cells and thus cause transfusion related acute lung injury.
Study design:
Single blind randomised control study with three study-arms in healthy volunteers.
Interventions:
All volunteers will receive i.v. injection of lipopolysaccharide (LPS) 2 ng/kg and 1 unit (300ml) of fresh red blood cells or 1 unit (300 ml) of stored red blood cells or 300ml of saline.
Main study endpoints:
Onset of lung injury by radiological imaging, pulmonary function tests, laboratory measurements, functional assays.
Study objective
LPS-primed neutrophils can be activated by stored red blood cells and thus cause transfusion related acute lung injury.
Study design
Visit 1: Screening
Visit 2: Blood donation
Visit 3: Study day
Visit 4: Follow-up
Intervention
All volunteers will receive i.v. injection of lipopolysaccharide (LPS) 2 ng/kg and 1 unit (300ml) of fresh red blood cells or 1 unit (300 ml of stored red blood cells or 300ml of saline.
Meibergdreef 9
A.L. Peters
Amsterdam 1105 AZ
The Netherlands
020-5668222
a.l.peters@amc.uva.nl
Meibergdreef 9
A.L. Peters
Amsterdam 1105 AZ
The Netherlands
020-5668222
a.l.peters@amc.uva.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4217 |
| NTR-old | NTR4455 |
| Other | AMC METC 2012-299 : ABR NL42360.018.12 |