Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT05179200
Eligibility Criteria:
Inclusion Criteria:
1. Donors must fulfil criteria for blood- and plasma donation according to Council of Europe's "Guide to the preparation, use and quality assurance of blood components" (14) and "Veileder i transfusjonsmedisin" (16)
2. Age: 18-64 years
3. Sex: Men
4. Estimated blood volume \> 4 500 ml
5. Weight \>50 kg
6. Donors must have performed at least one plasmapheresis earlier (start at least 2 months after last donation)
7. Good vein quality for plasmapheresis
8. Total serum protein\>60 g/L
9. Serum IgG\>6.0 g/L
10. Haemoglobin\>13.5 g/dL
Exclusion Criteria:
1. Hct \>50 %.
2. Medications or medical history not compatible with blood- or plasma donations, for example treatment with angiotensin converting enzyme (ACE) inhibitors, according to guidelines in inclusion criteria
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT05179200
Study Brief:
Protocol Section:
NCT05179200