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

NCT05549232 | Completed Results DMC FDA Device

• 1 other identifier: PRO-CLIN-0012
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Neoplasms; Burns

Keywords

Transfusion; Red Blood Cells; Hypoxic

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.

  The type and the grade of each adverse event will be categorized according to: * Association for the Advancement of Blood and Biotherapies (AABB) technical manual, 20th edition (2020) * Biomedical Excellence for Safer Transfusion (BEST) Collaborative review - Lancet 2016; 388: 2825-36 * Local AEs database (for reference) * ISO 14155-2020 definitions

  24 hours

• Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.

  The type and the grade of each adverse event will be categorized according to: * Association for the Advancement of Blood and Biotherapies (AABB) technical manual, 20th edition (2020) * Biomedical Excellence for Safer Transfusion (BEST) Collaborative review - Lancet 2016; 388: 2825-36 * Local AEs database (for reference) * ISO 14155-2020 definitions

  7 days (+/-1 day)

Secondary Outcomes (9)

• Evolution of the Hemoglobin Level Before and After the Transfusion.

  pre-transfusion to up to 30 minutes post-transfusion

• Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose

  28 days

• Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion

  28 days

• Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First

  28 days

• Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion

  baseline up to 15 minutes post-transfusion.

Study Arms (2)

Hematologic Malignancies

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.

Device: Hypoxic Red Blood Cells

Acute Burn

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.

Device: Hypoxic Red Blood Cells

Interventions

Hypoxic Red Blood Cells DEVICE

Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced

Acute Burn; Hematologic Malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 acute burn patients and 10 patients with hematological malignancies, who require transfusion of red cells concentrates and who fulfill all eligibility criteria will be enrolled in this clinical investigation at Haukeland University Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hemanext: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (3)

• Yoshida 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 BACKGROUND

• Williams 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 BACKGROUND

• D'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 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Burns; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Wounds and Injuries; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sr. Director, Clinical Affairs
• Organization: Hemanext Inc.

jill.bagdasarian@hemanext.com

781-301-7474

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 22, 2022
• Study Start: August 24, 2022
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: July 23, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)