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

Hemanext

Status: Completed

Conditions: Hematologic Neoplasms; Burns

Treatments: Device: Hypoxic Red Blood Cells

Study type: Observational

Funder types: Industry

Identifiers

NCT05549232

PRO-CLIN-0012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

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.

Treatment:

Device: Hypoxic Red Blood Cells

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.

Treatment:

Device: Hypoxic Red Blood Cells