PMID- 37423867
OWN - NLM
STAT- MEDLINE
DCOM- 20231127
LR  - 20231127
IS  - 1473-0502 (Print)
IS  - 1473-0502 (Linking)
VI  - 62
IP  - 5
DP  - 2023 Oct
TI  - Safety of hypoxic red blood cell administration in patients with 
      transfusion-dependent hematological malignancies: An interim analysis.
PG  - 103755
LID - S1473-0502(23)00139-8 [pii]
LID - 10.1016/j.transci.2023.103755 [doi]
AB  - Anemia is a common symptom of hematological malignancies and red blood cell (RBC) 
      transfusion is the primary supportive treatment, with many patients becoming 
      transfusion dependent. Hemanext Inc. (Lexington, MA, United States) has developed 
      a CE mark certified device to process and store RBCs hypoxically - 
      citrate-phosphatedextrose 
      (CPD)/phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) RBCs, 
      leukocytes-reduced (LR), O(2)/CO(2) reduced - with the aim of improving RBC 
      quality for transfusion. This interim analysis describes the first patients to 
      receive hypoxic RBCs, administered as part of a pilot post-marketing study in 
      Norway. The primary outcome was adverse events (AEs) within 24 h of transfusion 
      initiation and overall up to 7 days ( +/- 1 day) post-transfusion. Secondary 
      outcomes included changes in hemoglobin levels post-transfusion. Five patients 
      with hematological malignancies were included (80 % male, mean age 69.8 [SD 
      +/- 19.3] years). Prior to the study, patients had been receiving conventional RBC 
      transfusions every two weeks. Patients received 2 units of hypoxic RBCs over 2 h 
      without complication. One mild AE (rhinovirus) was reported two days 
      post-treatment and was deemed unrelated to treatment. The mean +/- SD 
      pre-transfusion hemoglobin level was 7.7 +/- 0.5 g/dL, evolving to 9.0 +/- 0.9 g/dL 
      following administration of hypoxic RBCs; an increase of 17 %. This interim 
      analysis showed that transfusion with hypoxic RBCs processed with the CPD/PAGGSM 
      LR, O(2)/CO(2) reduced system was effective and well tolerated in patients with 
      hematologic malignancies. The overall clinical program will assess whether the 
      use of hypoxic RBCs can reduce transfusion interval versus conventional RBCs in 
      patients requiring acute and chronic transfusions.
CI  - Copyright (c) 2023. Published by Elsevier Ltd.
FAU - Reikvam, Hakon
AU  - Reikvam H
AD  - Department of Clinical Science, University of Bergen, 5007 Bergen, Norway; 
      Department of Clinical Medicine, University of Bergen, 5007 Bergen, Norway. 
      Electronic address: Hakon.Reikvam@uib.no.
FAU - Hetland, Geir
AU  - Hetland G
AD  - Oslo University Hospital, P. O. Box 4950 Nydalen, N-0424 Oslo, Norway; Institute 
      of Clinical Medicine, University of Oslo, N-0424 Oslo, Norway.
FAU - Ezligini, Farshid
AU  - Ezligini F
AD  - Oslo University Hospital, P. O. Box 4950 Nydalen, N-0424 Oslo, Norway.
FAU - Dorsch, Kim
AU  - Dorsch K
AD  - Hemanext Inc., 99 Hayden Ave building b suite 620, Lexington, MA 02421, USA.
FAU - Omert, Laurel
AU  - Omert L
AD  - Hemanext Inc., 99 Hayden Ave building b suite 620, Lexington, MA 02421, USA.
FAU - Dunham, Andrew
AU  - Dunham A
AD  - Hemanext Inc., 99 Hayden Ave building b suite 620, Lexington, MA 02421, USA.
FAU - Almeland, Stian K
AU  - Almeland SK
AD  - Department of Clinical Medicine, University of Bergen, 5007 Bergen, Norway; 
      Haukeland University Hospital, Jonas Lies vei 65, 5021 Bergen, Norway.
LA  - eng
PT  - Journal Article
DEP - 20230622
PL  - England
TA  - Transfus Apher Sci
JT  - Transfusion and apheresis science : official journal of the World Apheresis 
      Association : official journal of the European Society for Haemapheresis
JID - 101095653
RN  - 142M471B3J (Carbon Dioxide)
RN  - 51404-37-6 (citrate phosphate dextrose)
RN  - 0 (Hemoglobins)
MH  - Humans
MH  - Male
MH  - Aged
MH  - Female
MH  - Carbon Dioxide
MH  - Erythrocytes/chemistry
MH  - *Anemia
MH  - *Hematologic Neoplasms/therapy/complications
MH  - Hypoxia/therapy
MH  - Hemoglobins/analysis
OTO - NOTNLM
OT  - Blood transfusion
OT  - Hypoxic processing
OT  - Hypoxic storage
OT  - MDS
OT  - Transfusion dependent
COIS- Conflicts of interest HR, GH, FE and SA declare no conflicts of interest. KD, LO, 
      and AD report employment with and stock in Hemanext, Inc.
EDAT- 2023/07/10 00:42
MHDA- 2023/11/27 12:44
CRDT- 2023/07/09 22:01
PHST- 2023/04/26 00:00 [received]
PHST- 2023/06/07 00:00 [revised]
PHST- 2023/06/20 00:00 [accepted]
PHST- 2023/11/27 12:44 [medline]
PHST- 2023/07/10 00:42 [pubmed]
PHST- 2023/07/09 22:01 [entrez]
AID - S1473-0502(23)00139-8 [pii]
AID - 10.1016/j.transci.2023.103755 [doi]
PST - ppublish
SO  - Transfus Apher Sci. 2023 Oct;62(5):103755. doi: 10.1016/j.transci.2023.103755. 
      Epub 2023 Jun 22.