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

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

Sponsors

Lead Sponsor: Hemanext

Source Hemanext
Brief Summary

The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies. The Hemanext ONE device received CE mark in April 2021.

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. 1. Assessment of pre and post transfusion hemoglobin levels 2. Assessment of hemoglobin level before the following transfusion, if applicable 3. 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. 4. Assessment of the vital signs during and up to 15 minutes after the transfusion.

Overall Status Recruiting
Start Date 2022-08-24
Completion Date 2023-05-31
Primary Completion Date 2023-05-31
Study Type Observational
Primary Outcome
Measure Time Frame
Number of participants who experienced an adverse event (all types/grades) within a time frame up to 24 hours following the transfusion and overall up to 7 days (+/- 1 day) after the transfusion. 7 days
Secondary Outcome
Measure Time Frame
Evolution of the hemoglobin level before and after the transfusion. 1 days
Calculation of the Hemoglobin increment after transfusion corrected for patient blood volume and hemoglobin dose 28 days
Comparison of the Hemoglobin level before the index transfusion to that prior to the subsequent transfusion (hematologic malignancy group only) 28 days
Evaluation of AEs from enrollment, up to prior to the subsequent transfusion or up to Day 28, whichever occurs first 28 days
Evaluation of subject's blood pressure over the course of the transfusion and up to 15 minutes post-transfusion 1 day
Evaluation of subject's respiratory rate over the course of the transfusion and up to 15 minutes post-transfusion 1 day
Evaluation of subject's SO2 level over the course of the transfusion and up to 15 minutes post-transfusion 1 day
Evaluation of subject's pulse over the course of the transfusion and up to 15 minutes post-transfusion 1 day
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: Hypoxic Red Blood Cells

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

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: A. Hematological malignancies patients group: 1. Male or female patients at least 18 years of age 2. Patients expected to require > 2 units of red blood cells in a single transfusion event 3. Patients who have the capacity to consent to participate and are willing to comply with the study procedures. 4. Patients identified by a Transfusion hemoglobin trigger of less than 9 g/dL 5. Patients with a documented diagnosis of leukemia, myelomatosis or MDS requiring chronic transfusions B. Burn patients group: 1. Male or female patients at least 18 years of age 2. Patients who have the capacity to consent by themselves to participate to the clinical investigation 3. Smaller burn patients, hospitalized with a Total Body Surface Area (TBSA%) burn ≥ 10% and ≤ 50% 4. Patients expected to require > 2 unit of red blood cells in a single transfusion event Exclusion Criteria: A. Both patients groups 1. Patients with any positive antibody screening test 2. Patients for whom consent has not been obtained 3. Patients with a known hemolytic anemia (congenital or acquired) 4. Patients < 18 years old 5. Patients with a known or suspected pregnancy 6. Patients with a history of major transfusion reactions 7. Patients whom the Investigator deems clinical trial participation is not in their best interest. B. Burn patients specific exclusion criteria : 1. Patients who do not have the capacity to consent by themselves to participate to the clinical investigation 2. Patients hospitalized with a Total body surface area (TBSA%) burn more than 50% 3. Patients with combined trauma in need of blood transfusions for treatment other than the burn excision

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Kimberly Dorsch

Phone: +1.781.301.7443

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Haukeland University Hospital Stian Almeland, MD +47 55 9750 [email protected] Hakon Reikvam, MD Sub-Investigator
Location Countries

Norway

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Hematologic Malignancies

Description: 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.

Label: Acute Burn

Description: 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.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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