Clinical trial NCT05549232: Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Neoplasms
Burns
Keywords: Transfusion
Red Blood Cells
Hypoxic
Lead sponsor: Hemanext
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (All Types/Grades) Within a Time Frame up to 24 Hours Following the Transfusion.
timeFrame: 24 hours
measure: Number of Participants Who Experienced an Adverse Event (AE) (All Types/Grades) Overall up to 7 Days (+/-1 Day) After the Transfusion.
timeFrame: 7 days (+/-1 day)
Secondary outcomes:
measure: Evolution of the Hemoglobin Level Before and After the Transfusion.
timeFrame: 1 days
measure: Calculation of the Hemoglobin Increment After Transfusion Corrected for Patient Blood Volume and Hemoglobin Dose
timeFrame: 28 days
measure: Comparison of the Hemoglobin Level Before the Index Transfusion to That Prior to the Subsequent Transfusion (Hematologic Malignancy Group Only)
timeFrame: 28 days
measure: Evaluation of AEs From Enrollment, up to Prior to the Subsequent Transfusion or up to Day 28, Whichever Occurs First
timeFrame: 28 days
measure: Evaluation of Subject's Blood Pressure Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
timeFrame: 1 day
measure: Evaluation of Subject's Respiratory Rate Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
timeFrame: 1 day
measure: Evaluation of Subject's SO2 Level Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
timeFrame: 1 day
measure: Evaluation of Subject's Pulse Over the Course of the Transfusion and up to 15 Minutes Post-transfusion
timeFrame: 1 day
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.