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

Development of a *two hit* in vivo autologous transfusion model in healthy volunteers - Development of a Transfusion Model in Healthy Volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39642

Enrollment

Registered

2013-01-07

Start date

2014-02-13

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

transfusie gerelateerde longschade acute hypoxia after blood transfusion

Interventions

Group 1: *First hit* Lipopolysaccharide (LPS) 2ng/kg + *Second hit* Saline Group 2: *First hit* LPS + *Second hit* Fresh Red Blood Cells (RBCs) (2 day storage) Group 3: *First hit* LPS + *Second hit

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Healthy male volunteer 2. Age * 18 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

Design outcomes

Primary

Measure	Time frame
A significant increase (p	—

Secondary

Measure	Time frame
1. A significant increase (p	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

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