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Quantifying Experimental Variability in Shear-Induced Hemolysis to Support Uncertainty-Aware Hemolysis Models
Christopher Blum1, Markus Mous1, Ulrich Steinseifer1
1Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Annals of Biomedical Engineering
|July 4, 2025
Summary
Intra-donor variability significantly impacts hemolysis measurements, exceeding differences between donors. Increasing sample size enhances measurement precision for reliable hemocompatibility testing.
Area of Science:
- Biomedical Engineering
- Hematology
- Medical Device Design
Background:
- Hemolysis models require experimental data for parameter fitting.
- Existing experiments often lack sufficient replicates, neglecting variability.
- This leads to oversimplified models and inaccurate hemolysis predictions.
Purpose of the Study:
- Quantify intra- and inter-donor variability in hemolysis at fixed conditions.
- Assess the impact of sample size on hemolysis measurement precision.
- Improve the reliability of hemolysis models and in silico predictions.
Main Methods:
- Human blood from five donors subjected to standardized shear stress and exposure time.
- 20 independent hemolysis index (HI) measurements per donor.
- Bootstrap analysis to evaluate sample size effects on confidence intervals.
Main Results:
- Intra-donor variability was four times greater than inter-donor variability.
- Increased sample size (2 to 20 replicates) significantly reduced confidence intervals.
- Small sample sizes may underestimate true hemolysis variability.
Conclusions:
- Intra-donor variability is a major source of uncertainty in hemolysis measurements.
- Higher replicate numbers are crucial for robust hemolysis estimates.
- Incorporate these findings into experimental design and models for improved hemocompatibility assessment.
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