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

NCT06685848 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-07

No results posted yet for this study

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.

Conditions

  • Hematologic Neoplasms

Interventions

DEVICE

Hemanext ONE system

Hypoxic red blood cells

DEVICE

Conventional RBCs

Conventional manufactured Red blood cells

Sponsors & Collaborators

  • Hemanext

    lead INDUSTRY

Principal Investigators

  • Håkon Reikvam, PhD, MD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-29
Primary Completion
2026-12-15
Completion
2026-12-15
FDA Device
Yes

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06685848 on ClinicalTrials.gov