Clinical trial · Observational
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burns | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypoxic Red Blood Cells | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hematologic Malignancies
- description
- Subjects requiring chronic transfusions with red blood cells for treatment of a hematologic malignancy will receive 1 transfusion with 2 units of hypoxic red blood cells manufactured with the Hemanext ONE device. The subjects will be monitored for all adverse events from Informed Consent through Day 28 or the subsequent standard of care transfusion, whichever occurs first.
- interventionNames
- Device: Hypoxic Red Blood Cells
- label
- Acute Burn
- description
- Subjects requiring transfusion with red blood cells during the excision procedure after an acute burn will receive 2 units of hypoxic red blood cells manufactured with the Hemanext ONE device. As the excision treatments require transfusion of more than 2 units of red blood cells, the first 2 units transfused during the procedure will be hypoxic red blood cells. The subjects will be monitored for all adverse events through Day 28.
- interventionNames
- Device: Hypoxic Red Blood Cells
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: A. Hematological malignancies patients group: 1. Male or female patients at least 18 years of age 2. Patients expected to require \> 2 units of red blood cells in a single transfusion event 3. Patients who have the capacity to consent to participate and are willing to comply with the study procedures. 4. Patients identified by a Transfusion hemoglobin trigger of less than 9 g/dL 5. Patients with a documented diagnosis of leukemia, myelomatosis or MDS requiring chronic transfusions B. Burn patients group: 1. Male or female patients at least 18 years of age 2. Patients who have the capacity to consent by themselves to participate to the clinical investigation 3. Smaller burn patients, hospitalized with a Total Body Surface Area (TBSA%) burn ≥ 10% and ≤ 50% 4. Patients expected to require \> 2 unit of red blood cells in a single transfusion event Exclusion Criteria: A. Both patients groups 1. Patients with any positive antibody screening test 2. Patients for whom consent has not been obtained 3. Patients with a known hemolytic anemia (congenital or acquired) 4. Patients \< 18 years old 5. Patients with a known or suspected pregnancy 6. Patients with a history of major transfusion reactions 7. Patients whom the Investigator deems clinical trial participation is not in their best interest. B. Burn patients specific exclusion criteria : 1. Patients who do not have the capacity to consent by themselves to participate to the clinical investigation 2. Patients hospitalized with a Total body surface area (TBSA%) burn more than 50% 3. Patients with combined trauma in need of blood transfusions for treatment other than the burn excision
References
Publications (3)
- BACKGROUNDYoshida T, Prudent M, D'alessandro A. Red blood cell storage lesion: causes and potential clinical consequences. Blood Transfus. 2019 Jan;17(1):27-52. doi: 10.2450/2019.0217-18. PMID 30653459
- BACKGROUNDWilliams AT, Jani VP, Nemkov T, Lucas A, Yoshida T, Dunham A, D'Alessandro A, Cabrales P. Transfusion of Anaerobically or Conventionally Stored Blood After Hemorrhagic Shock. Shock. 2020 Mar;53(3):352-362. doi: 10.1097/SHK.0000000000001386. PMID 31478989
- BACKGROUNDD'Alessandro A, Yoshida T, Nestheide S, Nemkov T, Stocker S, Stefanoni D, Mohmoud F, Rugg N, Dunham A, Cancelas JA. Hypoxic storage of red blood cells improves metabolism and post-transfusion recovery. Transfusion. 2020 Apr;60(4):786-798. doi: 10.1111/trf.15730. Epub 2020 Feb 27. PMID 32104927