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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.
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:
i. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 7 days (+/-1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-transfusion to up to 30 minutes post-transfusion |
| Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose |
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Inclusion Criteria:
A. Hematological malignancies patients group:
B. Burn patients group:
Exclusion Criteria:
A. Both patients groups
B. Burn patients specific exclusion criteria :
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30653459 | Background | 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. | |
| 31478989 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| 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. | Posted | Count of Participants | Participants | 24 hours |
|
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:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oliguria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Affairs | Hemanext Inc. | 781-301-7474 | jill.bagdasarian@hemanext.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2023 | May 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2024 | May 1, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D002056 | Burns |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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. |
| 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. | 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 | 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. | 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. | 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. | 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. | 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 | baseline to up to 15 minutes post-transfusion |
| 32104927 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| Primary | 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:
| Participants in the Safety analysis set. Participants who did not receive a transfusion were not included in the analysis. | Posted | Count of Participants | Participants | 7 days (+/-1 day) |
|
|
|
| Secondary | 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. | Safety analysis set. Participants who did not receive a transfusion were not included in the analysis | Posted | Mean | Standard Deviation | g/dL | pre-transfusion to up to 30 minutes post-transfusion |
|
|
|
| Secondary | 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. | 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. | Posted | 28 days |
|
|
| Secondary | 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. | Safety analysis set. Participants who did not receive a transfusion were not included in the analysis. | Posted | Mean | Standard Deviation | g/dL | 28 days |
|
|
|
| Secondary | 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 | Safety analysis set. Participants who did not receive a transfusion were not included in the analysis. | Posted | Number | adverse event | 28 days |
|
|
|
| Secondary | 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. | Safety analysis set. Participants who did not receive a transfusion were not included in the analysis. | Posted | Mean | Standard Deviation | mmHg | baseline up to 15 minutes post-transfusion. |
|
|
|
| Secondary | 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. | Safety analysis set. Participants who did not receive a transfusion were not included in the analysis. | Posted | Mean | Standard Deviation | mmHg | baseline up to 15 minutes post-transfusion. |
|
|
|
| Secondary | 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. | Safety analysis set. Participants who did not receive a transfusion were not included in the analysis. | Posted | Mean | Standard Deviation | breaths/min | baseline to up to 15 minutes post-transfusion |
|
|
|
| Secondary | 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. | Safety analysis set. Participants who did not receive a transfusion were not included in in analysis. | Posted | Mean | Standard Deviation | % O2 saturation | baseline to up to 15 minutes post-transfusion |
|
|
|
| Secondary | 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 | Safety analysis set. Participants who did not receive a transfusion were not included in analysis. | Posted | Mean | Standard Deviation | beats/min | baseline to up to 15 minutes post-transfusion |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | 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 | 0 | 12 | 1 | 12 | 6 | 12 |
| Wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site extravasation | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
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.
| D014947 |
| Wounds and Injuries |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |