Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion
Sponsor: Hemanext
Summary
The overall objective of this study is to collect preliminary effectiveness and safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021 and marketing authorization through the FDA De Novo process in September 2023.
Official title: Multi-Center, Randomized, Controlled Cross-Over Study to Evaluate Safety and Effectiveness of Hypoxic RBCs Processed With the Hemanext ONE System vs Conventional RBCs in Patients With Transfusion-Dependent Haematological Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-11-29
Completion Date
2028-08
Last Updated
2026-08-14
Healthy Volunteers
No
Conditions
Interventions
Hemanext ONE system
Hypoxic red blood cells
Conventional RBCs
Conventional manufactured Red blood cells
Locations (2)
Duke University Health System
Durham, North Carolina, United States
Haukeland University Hospital
Bergen, Norway