LPS-primed neutrophils can be activated by stored red blood cells and thus cause transfusion related acute lung injury.
ID
Bron
Verkorte titel
Aandoening
Transfusion related acute lung injury
Healthy Volunteers
Storage
Transfusion
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Onset of lung injury measured by laboratory measurements, functional assays, radiological imaging, pulmonary function tests.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
LPS-primed neutrophils can be activated by stored red blood cells and thus cause transfusion related acute lung injury.
Onderzoeksopzet
Visit 1: Screening
Visit 2: Blood donation
Visit 3: Study day
Visit 4: Follow-up
Onderzoeksproduct en/of interventie
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.
Publiek
Meibergdreef 9
A.L. Peters
Amsterdam 1105 AZ
The Netherlands
020-5668222
a.l.peters@amc.uva.nl
Wetenschappelijk
Meibergdreef 9
A.L. Peters
Amsterdam 1105 AZ
The Netherlands
020-5668222
a.l.peters@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Healthy male volunteer
2. Age ≥ 18 years <35 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4217 |
| NTR-old | NTR4455 |
| Ander register | AMC METC 2012-299 : ABR NL42360.018.12 |