Protein Deficiency clinical trials

The Effect of Plasma Donation Frequency on Donor Health

This project is a randomized controlled non-inferiority study that aims to cover knowledge gaps about the composition and development of plasma proteins, inflammation markers and mental health in Norwegian, voluntary, and unpaid blood donors who donate plasma and blood. We will include 120 male blood donors who are randomized into three groups, the first donating plasma by plasmapheresis 3 times every 2 weeks, the second donating plasma by plasmapheresis every 2 weeks and the third donating whole blood every 3 months. Blood sample analyses are done before, every 2 weeks during the donation period and after the donation period. Questionnaires regarding mental symptoms, Hopkins Symptoms Checklist 25, are done before and after the donation period. The donations extend over 16 weeks and the participants are followed up with blood tests 2 and 4 weeks after the last donation. A plasma sample from each sampling will be stored in an biobank in Innlandet Hospital Trust. The donation frequency are based on the Council of Europe's latest guidelines for plasmapheresis which allow 33 plasma donations per year with at least 96-hour intervals and previous national guidelines. The project is useful to ensure that frequent plasma donations, which are necessary to increase plasma production and the degree of self-sufficiency of plasma products in Norway, do not pose a health risk to blood donors. The primary objective is to assess the safety of blood donors donating plasma, by comparing the change in total protein and immunoglobulin G concentrations between donors who will be donating plasma 3 times every 2 weeks with donors donating plasma every 2 weeks and blood donors donating regular whole blood every 3 months. The secondary objectives are to compare the concentrations of other plasma proteins and inflammation markers and describe the development of these during plasma and blood donations between the three donations groups, compare the dropout rate and the degree of psychological distress measured by Hopkins Symptoms Checklist 25.