N/A N=22

Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital

Hematologic Neoplasms · Burns

Bottom Line

View on ClinicalTrials.gov: NCT05549232 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

May 2025

Primary outcome: Primary: Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion. — 2; 3 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Hypoxic Red Blood Cells (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hemanext
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.	2; 3	—
PRIMARY Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.	4; 7	—
SECONDARY Evolution of the Hemoglobin Level Before and After the Transfusion.	1.20; 0.25	—
SECONDARY Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose	—	—
SECONDARY Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion	0.21; 0.84	—
SECONDARY Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First	4; 7	—
SECONDARY Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	-0.44; 1.90	—
SECONDARY Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	-0.44; 1.90	—
SECONDARY Evaluation of Subject's Respiratory Rate Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	0.00; -1.10	—
SECONDARY Evaluation of Subject's SO2 Level Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	0.22; 0.00	—
SECONDARY Evaluation of Subject's Pulse Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	-3.33; 5.40	—

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.

Eligibility Criteria

Inclusion Criteria

A. Hematological malignancies patients group:

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

B. Burn patients group:

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%
Patients expected to require > 2 unit of red blood cells in a single transfusion event

Exclusion Criteria

A. Both patients groups

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
Patients with a history of major transfusion reactions
Patients whom the Investigator deems clinical trial participation is not in their best interest.

B. Burn patients specific exclusion criteria :

Patients who do not have the capacity to consent by themselves to participate to the clinical investigation
Patients hospitalized with a Total body surface area (TBSA%) burn more than 50%
Patients with combined trauma in need of blood transfusions for treatment other than the burn excision

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05549232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.