Trial Outcomes & Findings for Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital (NCT NCT05549232)

NCT ID: NCT05549232

Last Updated: 2025-07-23

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 22 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2025-07-23

Participant Flow

Participant milestones

Measure	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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Overall Study STARTED	10	12
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=12 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	72.0 years STANDARD_DEVIATION 16.41 • n=5 Participants	49.6 years STANDARD_DEVIATION 19.46 • n=7 Participants	59.8 years STANDARD_DEVIATION 21.08 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Norway	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: 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.

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

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.	2 Participants	3 Participants

PRIMARY outcome

Timeframe: 7 days (+/-1 day)

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

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

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.	4 Participants	7 Participants

SECONDARY outcome

Timeframe: pre-transfusion to up to 30 minutes post-transfusion

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

The difference in measured hemoglobin (grams/dL) between pre-transfusion and up to 30 minutes post-transfusion.

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evolution of the Hemoglobin Level Before and After the Transfusion.	1.20 g/dL Standard Deviation 0.494	0.25 g/dL Standard Deviation 0.981

SECONDARY outcome

Timeframe: 28 days

Population: Outcome not analyzed. The reason for this change is that it was not possible to calculate the hemoglobin increment from the collected data. Patient HgB results were collected pre and post transfusion. However, total HgB transfused (i.e. how much HgB was present in RBC units) was not assessed. This missing variable is required to complete the HgB Increment calculation, which prevented us from completing the calculation in order to report adjusted hemoglobin increment.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 28 days

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

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.

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion	0.21 g/dL Standard Deviation 1.177	0.84 g/dL Standard Deviation 2.065

SECONDARY outcome

Timeframe: 28 days

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

Number of AEs that occur from enrollment, up to prior to the subsequent transfusion or up to Day 28, whichever occurs first

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First	4 adverse event	7 adverse event

SECONDARY outcome

Timeframe: baseline up to 15 minutes post-transfusion.

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

Change in blood pressure (systolic; mmHg) from baseline up to 15 minutes post-transfusion.

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	-4.56 mmHg Standard Deviation 6.521	-3.40 mmHg Standard Deviation 23.996

SECONDARY outcome

Timeframe: baseline up to 15 minutes post-transfusion.

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

Change in blood pressure (diastolic; mmHg) from baseline up to 15 minutes post-transfusion.

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	-0.44 mmHg Standard Deviation 7.333	1.90 mmHg Standard Deviation 9.219

SECONDARY outcome

Timeframe: baseline to up to 15 minutes post-transfusion

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

Change in respiratory rate (breaths per minute) from baseline to up to 15 minutes post-transfusion.

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evaluation of Subject's Respiratory Rate Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	0.00 breaths/min Standard Deviation 2.062	-1.10 breaths/min Standard Deviation 2.846

SECONDARY outcome

Timeframe: baseline to up to 15 minutes post-transfusion

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

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.

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evaluation of Subject's SO2 Level Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	0.22 % O2 saturation Standard Deviation 1.856	0.00 % O2 saturation Standard Deviation 1.633

SECONDARY outcome

Timeframe: baseline to up to 15 minutes post-transfusion

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

Change in heart rate (beats per minute) from baseline to up to 15 minutes post-transfusion

Outcome measures

Measure	Hematologic Malignancies n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=10 Participants 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Evaluation of Subject's Pulse Over the Course of the Transfusion and up to 15 Minutes Post-transfusion	-3.33 beats/min Standard Deviation 6.144	5.40 beats/min Standard Deviation 16.263

Adverse Events

Hematologic Malignancies

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Acute Burn

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hematologic Malignancies n=10 participants at risk 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=12 participants at risk 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
Renal and urinary disorders Oliguria	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Infections and infestations Wound infection	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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

Other adverse events

Measure	Hematologic Malignancies n=10 participants at risk 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced	Acute Burn n=12 participants at risk 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. Hypoxic Red Blood Cells: Hypoxic Red Blood Cells manufactured with the Hemanext ONE device- CPD/PAGGSM Red Blood Cells, Leukocytes Reduced, and O2/CO2 Reduced
General disorders Pyrexia	10.0% 1/10 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	25.0% 3/12 • Number of events 3 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
General disorders Catheter site extravasation	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	16.7% 2/12 • Number of events 2 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Infections and infestations Nasopharyngitis	20.0% 2/10 • Number of events 2 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	0.00% 0/12 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	0.00% 0/12 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 1/10 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	0.00% 0/12 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Cardiac disorders Atrial fibrillation	10.0% 1/10 • Number of events 2 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	0.00% 0/12 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Gastrointestinal disorders Nausea	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Injury, poisoning and procedural complications Wound complication	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Musculoskeletal and connective tissue disorders Muscle spasms	10.0% 1/10 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	0.00% 0/12 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Psychiatric disorders Sleep disorder	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Surgical and medical procedures Spinal operation	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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
Vascular disorders Hypertension	0.00% 0/10 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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	8.3% 1/12 • Number of events 1 • Adverse Events reported up to 28 days post-transfusion, or up to subsequent transfusion episode, whichever comes first The type and the grade of each adverse event were 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

Additional Information

Sr. Director, Clinical Affairs

Hemanext Inc.

Phone: 781-301-7474

Email: jill.bagdasarian@hemanext.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI shall provide Sponsor with a copy of the papers, abstracts or presentations not less than thirty (30) days prior to submission to a scientific journal or presentation at scientific meetings. Sponsor shall have thirty (30) days to review the proposed publication. Sponsor may comment upon, but may not make any editorial changes to, the results and conclusions set forth in the papers unless Confidential Information is identified and must be deleted.
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