Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital (NCT05549232) | Clinical Trial Compass
CompletedNot Applicable
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
Norway22 participantsStarted 2022-08-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients at least 18 years of age
✓. Patients expected to require \> 2 units of red blood cells in a single transfusion event
✓. Patients who have the capacity to consent to participate and are willing to comply with the study procedures.
✓. Patients identified by a Transfusion hemoglobin trigger of less than 9 g/dL
✓. Patients with a documented diagnosis of leukemia, myelomatosis or MDS requiring chronic transfusions
✓. Male or female patients at least 18 years of age
✓. Patients who have the capacity to consent by themselves to participate to the clinical investigation
✓. Smaller burn patients, hospitalized with a Total Body Surface Area (TBSA%) burn ≥ 10% and ≤ 50%
Exclusion criteria
✕. Patients with any positive antibody screening test
✕. Patients for whom consent has not been obtained
✕. Patients with a known hemolytic anemia (congenital or acquired)
✕. Patients \< 18 years old
✕. Patients with a known or suspected pregnancy
What they're measuring
1
Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.
Timeframe: 24 hours
2
Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.