At a glance
ClinicalIndex Comparison RecordN/ACompleted· 22 enrolled
Drug / intervention
Hypoxic Red Blood Cellsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Pilot Clinical Investigation of Surgical Bleeding in Burn Patients, and Chronically Transfused Patients With Haematologic Malignancies, Who Are Transfused With Hypoxic Red Blood Cells Manufactured With Hemanext ONE System
In Brief
An observational study evaluating Hypoxic Red Blood Cells for Hematologic Neoplasms and Burns. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Neoplasms, Burns
CountriesNorway
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
Enrollment StartAug 2022
First PostedSep 2022
Primary CompletionMay 2024
TodayJul 2026
First PostedSep 22, 2022
Enrollment StartAug 24, 2022
Primary CompletionMay 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.8 years ago
Interventions
Hypoxic Red Blood Cellsdevice
Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced