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Transfusion model in healthy volunteers


- candidate number17024
- NTR NumberNTR4455
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mrt-2014
- Secondary IDsABR NL42360.018.12 AMC METC 2012-299
- Public TitleTransfusion model in healthy volunteers
- Scientific TitleA “two hit” in vivo autologous transfusion model in healthy volunteers
- ACRONYMTRALI
- hypothesisLPS-primed neutrophils can be activated by stored red blood cells and thus cause transfusion related acute lung injury.
- Healt Condition(s) or Problem(s) studiedHealthy volunteers, Blood transfusions
- Inclusion criteria1. Healthy male volunteer 2. Age ≥ 18 years <35 years
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-apr-2014
- planned closingdate31-dec-2015
- Target number of participants18
- InterventionsAll 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.
- Primary outcomeOnset of lung injury measured by laboratory measurements, functional assays, radiological imaging, pulmonary function tests.
- Secondary outcome1. Markers of inflammation and coagulation 2. Identification of potential bio-markers for diagnosing TRALI
- TimepointsVisit 1: Screening Visit 2: Blood donation Visit 3: Study day
- Trial web site-
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES A.L. Peters
- CONTACT for SCIENTIFIC QUERIESDr. A.P.J. Vlaar
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
VENI, ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryObjective: 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.
- Main changes (audit trail)8-sep-2014: "After a successful pilot experiment in Augustus 2014, volunteers will also receive an infusion of biotin labelled red blood cells to facilitate identification of phenotypic changes of the transfused red blood cell.
An additional visit has been added to the study: Visit 4: Follow-up" - AB
- RECORD27-mrt-2014 - 31-mei-2015


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