Hematologic NeoplasmsNCT05549232

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

An observational study of Hematologic Neoplasms and Burns, run by Hemanext at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Neoplasms, Burns
What is being tested?: Hypoxic Red Blood Cells
Type of treatment: Medical device
How many people: 22 participants
Where: 1 siteNorway
Study dates: 24 Aug 2022to 16 May 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

Haukeland University Hospital
Bergen, 5021

Other trials in Norway

About this study

Official title: 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

Read the detailed description

The primary objective is to assess hypoxic RBCs safety and tolerance assessment up to 24 hours following the transfusion initiation and overall up to 7 days (+/- 1 day) after the transfusion episode (single transfusion course).

Secondary objectives include the following.

Assessment of pre and post transfusion hemoglobin levels
Assessment of hemoglobin level before the following transfusion, if applicable
Assessment of AEs occurrence:
Up to 7 days (+/- 1 day) post transfusion, in comparison with historical control (including but not limited to infection, deep vein thrombosis, acute respiratory distress syndrome, transfusion-related acute lung injury, transfusion associated circulatory overload, anaphylactic shock, acute hemolytic transfusion reaction). ii. Up to the subsequent transfusion episode or up to 28 days (+/- 1 day) after the initial transfusion, whichever comes first. iii. From enrollment, up to their subsequent transfusion or 28 days (+/- 1 day) post transfusion, whichever comes first, through the assessment of patient's diary.
Assessment of the vital signs during and up to 15 minutes after the transfusion.

Conditions: Hematologic Neoplasms, Burns
Being tested: Hypoxic Red Blood Cells
Keywords: Transfusion, Red Blood Cells, Hypoxic
Medical subject headings: Hematologic Neoplasms, Burns, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05549232
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Hypoxic Red Blood Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 7 days (+/-1 day)

Secondary outcomes (9)

Evolution of the Hemoglobin Level Before and After the Transfusion.
The difference in measured hemoglobin (grams/dL) between pre-transfusion and up to 30 minutes post-transfusion.
Measured: pre-transfusion to up to 30 minutes post-transfusion
Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose
The hemoglobin increment from each transfusion will be determined by calculating the difference between the subject's post-transfusion and pre-transfusion hemoglobin (g/dL). It will then be corrected for estimated subject blood volume and the amount of Hb transfused.
The following equation used for the hemoglobin increment calculation:
HgB Increment = (Subject's HgB level post-transfusion - Subject's HgB pre-transfusion)/ (total HgB transfused x Subject's BloodVolume)
Equations for calculating the hemoglobin increment may be found in the following publication: Wendelbo Ø, Opheim EN, Hervig T, Felli Lunde TH, Bruserud Ø, Mollnes TE, Reikvam H. Cytokine profiling and post-transfusion haemoglobin increment in patients with haematological diseases. Vox Sang. 2018 Oct;113(7):657-668. doi: 10.1111/vox.12703. Epub 2018 Aug 29. PMID: 30159896.
Measured: 28 days
Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion
The difference in measured hemoglobin (grams/dL) between the pre-transfusion hemoglobin level for the study transfusion and the pre-transfusion hemoglobin level for the next scheduled transfusion.
Measured: 28 days
Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First
Number of AEs that occur from enrollment, up to prior to the subsequent transfusion or up to Day 28, whichever occurs first
Measured: 28 days
Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Change in blood pressure (systolic; mmHg) from baseline up to 15 minutes post-transfusion.
Measured: baseline up to 15 minutes post-transfusion.
Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Change in blood pressure (diastolic; mmHg) from baseline up to 15 minutes post-transfusion.
Measured: baseline up to 15 minutes post-transfusion.
Evaluation of Subject's Respiratory Rate Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Change in respiratory rate (breaths per minute) from baseline to up to 15 minutes post-transfusion.
Measured: baseline to up to 15 minutes post-transfusion
Evaluation of Subject's SO2 Level Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Change in the amount of oxygen in the body (% S02 level), measured with a pulse oximeter, from baseline to up to 15 minutes post-transfusion.
Measured: baseline to up to 15 minutes post-transfusion
Evaluation of Subject's Pulse Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Change in heart rate (beats per minute) from baseline to up to 15 minutes post-transfusion
Measured: baseline to up to 15 minutes post-transfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Aug 202216 May 2024

First posted22 Sep 2022
Study start24 Aug 2022
Primary completion16 May 2024
Study completion16 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05549232
Sponsor's protocol ID: PRO-CLIN-0012
Status last verified: Jul 2025
First submitted: 29 Aug 2022
Last updated: 23 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 30653459
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.
PubMed 31478989
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.
PubMed 32104927

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05549232
Acronym / sponsor ID: PRO-CLIN-0012
Conditions: Hematologic Neoplasms, Burns
Keywords: Transfusion, Red Blood Cells, Hypoxic
Study type: Observational
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: HemanextIndustry (pharma, biotech, devices)
Study start: 24 Aug 2022 (actual)
Primary completion: 16 May 2024 (actual)
Study completion: 16 May 2024 (actual)
First posted: 22 Sep 2022 (actual)
Results: Posted 18 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Secondary objectives include the following.

Assessment of pre and post transfusion hemoglobin levels
Assessment of hemoglobin level before the following transfusion, if applicable
Assessment of AEs occurrence:
Up to 7 days (+/- 1 day) post transfusion, in comparison with historical control (including but not limited to infection, deep vein thrombosis, acute respiratory distress syndrome, transfusion-related acute lung injury, transfusion associated circulatory overload, anaphylactic shock, acute hemolytic transfusion reaction). ii. Up to the subsequent transfusion episode or up to 28 days (+/- 1 day) after the initial transfusion, whichever comes first. iii. From enrollment, up to their subsequent transfusion or 28 days (+/- 1 day) post transfusion, whichever comes first, through the assessment of patient's diary.
Assessment of the vital signs during and up to 15 minutes after the transfusion.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Hematologic Malignancies	–	Device: Hypoxic Red Blood CellsSubjects 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.
Acute Burn	–	Device: Hypoxic Red Blood CellsSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (11 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypoxic Red Blood CellsHypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Device	Acute Burn, Hematologic Malignancies

Primary outcome

Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.
Time frame: 24 hours
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
Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.
Time frame: 7 days (+/-1 day)
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

9 secondary outcomes

Evolution of the Hemoglobin Level Before and After the Transfusion.
Time frame: pre-transfusion to up to 30 minutes post-transfusion
Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose
Time frame: 28 days
Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion
Time frame: 28 days
Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First
Time frame: 28 days
Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Time frame: baseline up to 15 minutes post-transfusion.
Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Time frame: baseline up to 15 minutes post-transfusion.
Evaluation of Subject's Respiratory Rate Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Time frame: baseline to up to 15 minutes post-transfusion
Evaluation of Subject's SO2 Level Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Time frame: baseline to up to 15 minutes post-transfusion
Evaluation of Subject's Pulse Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
Time frame: baseline to up to 15 minutes post-transfusion

Results and safety

Results posted to the registry on 18 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hematologic Malignancies	10	9
Acute Burn	12	10

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

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	Hematologic Malignancies n = 10	Acute Burn n = 10
Value	2	3

Population analysed: Participants in the Safety analysis set who experienced an adverse event (all types/grades) within a time frame up to 24 hours following transfusion. Participants who did not receive a transfusion were not included in the analysis.

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

Time frame: 7 days (+/-1 day). Count of participants. Unit: Participants

Measure	Hematologic Malignancies n = 10	Acute Burn n = 10
Value	4	7

Population analysed: Participants in the Safety analysis set. Participants who did not receive a transfusion were not included in the analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hematologic Malignancies	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Acute Burn	1 of 12 (8.3%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30653459Yoshida 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.
Background: PubMed 31478989Williams 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.
Background: PubMed 32104927D'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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Neoplasms and Burns, run by Hemanext at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion. (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05549232, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.