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Transfusion model in healthy volunteers

A “two hit” in vivo autologous transfusion model in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27952
Enrollment
18
Registered
2014-03-27
Start date
2014-04-03
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Transfusion related acute lung injury Healthy Volunteers Storage Transfusion

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.

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male volunteer 2. Age &#8805; 18 years <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, 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 outcomes

Primary

MeasureTime frame
Onset of lung injury measured by laboratory measurements, functional assays, radiological imaging, pulmonary function tests.

Secondary

MeasureTime frame
1. Markers of inflammation and coagulation 2. Identification of potential bio-markers for diagnosing TRALI

Contacts

Public ContactA.L. Peters

Department of Intensive Care Medicine and LEICA Meibergdreef 9

a.l.peters@amc.uva.nl020-5668222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)