TRansfusion strategies in Acute brain INjured patients (TRAIN): a prospective multicenter randomized interventional trial protocol.
Anemia
Brain injury
Brain perfusions
Clinical study
Outcome
Randomized controlled trial
Tissue hypoxia
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
07 Jan 2023
07 Jan 2023
Historique:
received:
12
11
2022
accepted:
30
12
2022
entrez:
7
1
2023
pubmed:
8
1
2023
medline:
11
1
2023
Statut:
epublish
Résumé
Although blood transfusions can be lifesaving in severe hemorrhage, they can also have potential complications. As anemia has also been associated with poor outcomes in critically ill patients, determining an optimal transfusion trigger is a real challenge for clinicians. This is even more important in patients with acute brain injury who were not specifically evaluated in previous large randomized clinical trials. Neurological patients may be particularly sensitive to anemic brain hypoxia because of the exhausted cerebrovascular reserve, which adjusts cerebral blood flow to tissue oxygen demand. We described herein the methodology of a prospective, multicenter, randomized, pragmatic trial comparing two different strategies for red blood cell transfusion in patients with acute brain injury: a "liberal" strategy in which the aim is to maintain hemoglobin (Hb) concentrations greater than 9 g/dL and a "restrictive" approach in which the aim is to maintain Hb concentrations greater than 7 g/dL. The target population is patients suffering from traumatic brain injury (TBI), subarachnoid hemorrhage (SAH), or intracerebral hemorrhage (ICH). The primary outcome is the unfavorable neurological outcome, evaluated using the extended Glasgow Outcome Scale (eGOS) of 1-5 at 180 days after the initial injury. Secondary outcomes include, among others, 28-day survival, intensive care unit (ICU) and hospital lengths of stay, the occurrence of extra-cerebral organ dysfunction/failure, and the development of any infection or thromboembolic events. The estimated sample size is 794 patients to demonstrate a reduction in the primary outcome from 50 to 39% between groups (397 patients in each arm). The study was initiated in 2016 in several ICUs and will be completed in December 2022. This trial will assess the impact of a liberal versus conservative strategy of blood transfusion in a large cohort of critically ill patients with a primary acute brain injury. The results of this trial will help to improve blood product and transfusion use in this specific patient population and will provide additional data in some subgroups of patients at high risk of brain ischemia, such as those with intracranial hypertension or cerebral vasospasm. ClinicalTrials.gov NCT02968654.
Sections du résumé
BACKGROUND
BACKGROUND
Although blood transfusions can be lifesaving in severe hemorrhage, they can also have potential complications. As anemia has also been associated with poor outcomes in critically ill patients, determining an optimal transfusion trigger is a real challenge for clinicians. This is even more important in patients with acute brain injury who were not specifically evaluated in previous large randomized clinical trials. Neurological patients may be particularly sensitive to anemic brain hypoxia because of the exhausted cerebrovascular reserve, which adjusts cerebral blood flow to tissue oxygen demand.
METHODS
METHODS
We described herein the methodology of a prospective, multicenter, randomized, pragmatic trial comparing two different strategies for red blood cell transfusion in patients with acute brain injury: a "liberal" strategy in which the aim is to maintain hemoglobin (Hb) concentrations greater than 9 g/dL and a "restrictive" approach in which the aim is to maintain Hb concentrations greater than 7 g/dL. The target population is patients suffering from traumatic brain injury (TBI), subarachnoid hemorrhage (SAH), or intracerebral hemorrhage (ICH). The primary outcome is the unfavorable neurological outcome, evaluated using the extended Glasgow Outcome Scale (eGOS) of 1-5 at 180 days after the initial injury. Secondary outcomes include, among others, 28-day survival, intensive care unit (ICU) and hospital lengths of stay, the occurrence of extra-cerebral organ dysfunction/failure, and the development of any infection or thromboembolic events. The estimated sample size is 794 patients to demonstrate a reduction in the primary outcome from 50 to 39% between groups (397 patients in each arm). The study was initiated in 2016 in several ICUs and will be completed in December 2022.
DISCUSSION
CONCLUSIONS
This trial will assess the impact of a liberal versus conservative strategy of blood transfusion in a large cohort of critically ill patients with a primary acute brain injury. The results of this trial will help to improve blood product and transfusion use in this specific patient population and will provide additional data in some subgroups of patients at high risk of brain ischemia, such as those with intracranial hypertension or cerebral vasospasm.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02968654.
Identifiants
pubmed: 36611210
doi: 10.1186/s13063-022-07061-7
pii: 10.1186/s13063-022-07061-7
pmc: PMC9825124
doi:
Substances chimiques
Hemoglobins
0
Banques de données
ClinicalTrials.gov
['NCT02968654']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
20Subventions
Organisme : European Society of Intensive Care Medicine
ID : Nexy GRANT 2014
Organisme : Fondation des Gueules Cassées
ID : 12-2021
Informations de copyright
© 2023. The Author(s).
Références
Stroke. 2010 Oct;41(10):2391-5
pubmed: 20798370
Lancet. 1988 Apr 2;1(8588):727-9
pubmed: 2895260
Crit Care Med. 2008 Jul;36(7):2070-5
pubmed: 18552682
Crit Care. 2012 Dec 12;16(2):R54
pubmed: 22471943
Crit Care. 2019 Mar 12;23(1):89
pubmed: 30871608
Curr Opin Anaesthesiol. 2004 Oct;17(5):363-9
pubmed: 17023891
JAMA. 2002 Sep 25;288(12):1499-507
pubmed: 12243637
J Neurotrauma. 1998 Aug;15(8):573-85
pubmed: 9726257
Transfus Med Hemother. 2021 Feb;48(1):60-68
pubmed: 33708053
JAMA. 2014 Jul 2;312(1):36-47
pubmed: 25058216
Neurocrit Care. 2009;10(2):157-65
pubmed: 19116699
Chest. 1999 Nov;116(5):1233-9
pubmed: 10559080
Ann Intensive Care. 2011 Oct 04;1:43
pubmed: 21970512
Intensive Care Med. 2020 Apr;46(4):673-696
pubmed: 31912207
Lancet. 1996 Oct 19;348(9034):1055-60
pubmed: 8874456
Crit Care. 2017 Jun 17;21(1):159
pubmed: 28623949
Neurosurgery. 1999 Jun;44(6):1237-47; discussion 1247-8
pubmed: 10371622
Crit Care. 2012 Jul 20;16(4):R128
pubmed: 22817913
Neurocrit Care. 2006;5(1):4-9
pubmed: 16960287
Anesthesiology. 2000 Oct;93(4):1004-10
pubmed: 11020755
Clin Chem. 2000 Aug;46(8 Pt 2):1270-6
pubmed: 10926921
Transfusion. 2000 Apr;40(4):457-60
pubmed: 10773059
Anesthesiology. 2008 Jan;108(1):31-9
pubmed: 18156879
Crit Care. 2016 Jun 17;20(1):152
pubmed: 27311626
N Engl J Med. 1999 Feb 11;340(6):409-17
pubmed: 9971864
Am J Med. 1996 Sep;101(3):299-308
pubmed: 8873492