Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06685848
NA

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

Sponsor: Hemanext

View on ClinicalTrials.gov

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

Interventions

DEVICE

Hemanext ONE system

Hypoxic red blood cells

DEVICE

Conventional RBCs

Conventional manufactured Red blood cells

Locations (2)

Duke University Health System

Durham, North Carolina, United States

Haukeland University Hospital

Bergen, Norway