DONOR-PROTECT
Redefining Standards for Sustainable Blood and Plasma Collections through Personalized Donor Health Protection Strategies
Europe faces a pressing challenge: the millions of annual blood and plasma donations fall short of meeting the growing demand for plasma-derived medicinal products (PDMPs). Frequent donations may pose risks to donor health, including iron depletion and protein loss. Current one-size-fits-all guidelines overlook individual differences, potentially jeopardizing both donor health and PDMP supply. Rigorous studies that limit bias are essential to develop sustainable blood and plasma procurement strategies that ensure a reliable blood product supply while protecting donor health.
DONOR-PROTECT addresses this by pioneering evidence-based, personalized strategies that optimize donations from resilient donors while protecting vulnerable ones, ensuring a sustainable and ethical blood and plasma supply. The project will develop and validate the first personalized donor health protection strategy, setting a new standard for safe donation practices. Tailored donation intervals and health interventions will be informed by individual donor profiles, supported by interdisciplinary expertise in epidemiology, immunology, biostatistics, data science, and ethics.
Randomized controlled trials (RCTs) will generate critical health data, forming the basis for an innovative algorithm to personalize donation schedules. This personalized donor health protection strategy will be tested and validated through an adaptive RCT, enabling real-time adjustments based on interim analyses. Donor well-being will be prioritized through these studies, including robust ethical, legal and societal evaluations.
This transformative approach replaces generic guidelines with tailored, data-driven solutions. By addressing safety gaps in high-frequency donations, DONOR-PROTECT safeguards donor health, ensures sustainable blood and plasma supplies, and informs EU-wide policy. Beyond advancing public health research, the project sets new ethical and scalable standards for personalized blood and plasma donation practices, contributing to innovation in donor health and sustainable blood and plasma supply.
Donating too often can lead to iron and protein deficiencies, with largely unknown consequences. But what ‘too often’ is for one person, may be relatively little for another.
