Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT05549232
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
Sponsor:
Hemanext
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: