The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC transfusion support for acute anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
81
Kerckhoff-Klinic GmbH
Bad Nauheim, Hesse, Germany
Klinikum der J.-W.-G.-Universität Frankfurt
Frankfurt, Germany
Primary Efficacy Endpoint - mean hemoglobin content
The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups
Time frame: Day 2
Primary Safety Endpoint - Adverse events
The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.
Time frame: 90 days
Secondary Efficacy Endpoint
Proportion of RBC components that have adenosine-5'-triphosphate (ATP) levels of greater than 2 μmol/L
Time frame: Day 35
Secondary Efficacy Endpoint
Proportion of RBC components that meet the European Union (EU) guideline for hemoglobin content, hematocrit, and hemolysis at the end of storage
Time frame: Day 35
Secondary Efficacy Endpoint
Proportion of RBC components that have plasma-free hemoglobin levels corresponding to ≤ 0.8% hemolysis
Time frame: Day 35
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