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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-24

Study Completion Date

2024-05-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematologic Neoplasms Burns

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No