NCT06685848

Comparison of Hemanext ONE® System and Conventional Red Blood Cell Transfusion

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Hemanext · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to evaluate whether the total number of hypoxically stored red blood cell (RBCs) units per unit of time transfused in patients with haematologic malignancies, requiring chronic blood transfusion therapy, is non-inferior to the total number of units of conventionally stored RBCs per unit of time transfused. Secondary objectives include the following: 1. Analysis of volume of blood transfused 2. Analysis of number of transfusion events throughout the study period 3. Key laboratory assessments (hemoglobin and hematocrit) and average hemoglobin increment after transfusions of hypoxically stored RBCs compared to that with conventionally stored RBCs 4. Evaluation of Quality of Life (QoL) 5. Change in serum ferritin 6. Safety assessment

Conditions

• Hematologic Neoplasms

Interventions

Type	Name	Description
DEVICE	Hemanext ONE system	Hypoxic red blood cells
DEVICE	Conventional RBCs	Conventional manufactured Red blood cells

Timeline

• Start date: 2024-11-29
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2024-11-13
• Last updated: 2026-01-07

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated device study