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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05179200
Other study ID # 238929
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 3, 2022
Est. completion date July 2024

Study information

Verified date April 2024
Source Sykehuset Innlandet HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Plasmapheresis
Plasma donation
Whole blood donation
Blood donation

Locations

Country Name City State
Norway Innlandet Hospital Trust Lillehammer

Sponsors (1)

Lead Sponsor Collaborator
Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Haugen M, Magnussen K, Aarsland TE, Nissen-Meyer LSH, Strand TA. The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial. Trials. 2024 Mar 11;25(1):175. doi: 10.1186/s13063-024-08035-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total serum protein and immunoglobulin G To compare change from baseline of the TSP (g/L) and IgG (g/L) concentrations at 16 weeks after donations between donors who will be donating plasma 3 times every 2 weeks, donors donating plasma every 2 weeks, and donors who donate whole blood every 3 months. Measured at week 16 after the donation period
Secondary Other biomarkers To compare change from baseline of the concentrations of other biomarkers (reflecting nutritional status, inflammation or other processes related to health and disease, such as plasma proteins, lipids and vitamins) at 16 weeks after donations, and describe the development of these during plasma and blood donations between the three donation groups Measured at week 16 after the donation period.
Secondary Dropout To compare the dropout rate and reasons for dropouts between the three donation groups. Week 0-20
Secondary Psychological distress To compare the degree of psychological distress, measured by Hopkins Symptoms Checklist 25 before and after donations, between the three donation groups Measured at week 16 after the donation period.
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