The Effect of Plasma Donation Frequency on Donor Health

NCT05179200 | Completed DMC

• 1 other identifier: 238929
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Distress; Protein Deficiency; Inflammation

Keywords

plasmapheresis; plasma donation; donor health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Other biomarkers

  Measured at week 16 after the donation period.

• Dropout

  Week 0-20

• Psychological distress

  Measured at week 16 after the donation period.

Study Arms (3)

Group 1: "Frequent plasma donors"

EXPERIMENTAL

Donors will donate 650 ml plasma (excluding anticoagulant) by plasmapheresis three times every 2 weeks for 16 weeks.

Procedure: Plasmapheresis

Group 2: "Regular plasma donors"

ACTIVE COMPARATOR

Donors will donate 650 ml plasma (excluding anticoagulant) by plasmapheresis once every 14 days for 16 weeks.

Procedure: Plasmapheresis

Group 3: "Regular whole blood donors"

PLACEBO COMPARATOR

Donors will donate 450 ml (405-495 ml) whole blood every 3 months for 16 weeks.

Procedure: Whole blood donation

Interventions

Plasmapheresis PROCEDURE

Plasma donation

Also known as: Plasma donation

Group 1: "Frequent plasma donors"; Group 2: "Regular plasma donors"

Whole blood donation PROCEDURE

Blood donation

Also known as: Blood donation

Group 3: "Regular whole blood donors"

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: We will restrict the participation to male participants to reduce the variability between the study participants. This will increase the statistical power of the study. This also allows higher donation volumes because of higher estimated total blood volume in men (a donation of 650 ml plasma excluding anticoagulant including blood samples, requires an estimated blood volume of minimum 4 500 ml). In subsequent studies, we will include female participants.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• Age: 18-64 years
• Sex: Men
• Estimated blood volume \> 4 500 ml
• Weight \>50 kg
• Donors must have performed at least one plasmapheresis earlier (start at least 2 months after last donation)
• Good vein quality for plasmapheresis
• Total serum protein\>60 g/L
• Serum IgG\>6.0 g/L
• Haemoglobin\>13.5 g/dL

You may not qualify if:

• Hct \>50 %.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (1)

Innlandet Hospital Trust

Lillehammer, 2609, Norway

Location

Related 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.

  PMID: 38468338 BACKGROUND

Related Links

• Full text link

MeSH Terms

Conditions

Protein Deficiency; Inflammation

Interventions

Plasmapheresis; Blood Donation

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tor A Strand, MD/PhD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyses will be blinded with regard to group identity.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants/blood donors will be randomized into three donor groups in a 1:1:1 ratio and donate for a 16 week donation period. Group 1 will donate 650 ml plasma (excluding anticoagulant) by plasmapheresis three times every 2 weeks, group 2 will donate 650 ml plasma (excluding anticoagulant) by plasmapheresis once every 14 days and group 3 will donate 450 ml (405-495 ml) whole blood every 3 months.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 5, 2022
• Study Start: January 3, 2022
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)