Traumatic Brain Injury Clinical Trial
Official title:
TRansfusion Strategies in Acute Brain INjured Patients: TRAIN Study: A Prospective Multicenter Randomized Interventional Study
A Prospective Multicenter Randomized Interventional Study. Blood transfusion can be lifesaving in extreme circumstances, in the absence of life threatening hemorrhage, the indications for transfusion are somewhat controversial. The aim of the current study is to determine whether a"liberal" strategy of maintaining Hb concentrations above 9 g/dL would result in a different neurological outcome when compared to a "restrictive" approach to red-cell transfusion to avoid hemoglobin concentrations < 7 g/dL in critically ill anemic patients (i.e. Hb< 9 g/dL) with acute brain injury.
Background: Although blood transfusions can be lifesaving in severe hemorrhage, they could
also result in several potential complications. As anemia has also been associated with poor
outcome in critically ill patients,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 dealing with the optimal
transfusion threshold. Neurological patients may be particularly sensitive to anemic brain
hypoxia because of the exhausted cerebro-vascular reserve, which adjust cerebral blood flow
to tissue oxygen demand.
Methods/Design: The investigators describe herein the methodology of a prospective,
multicenter, randomized, pragmatic trial comparing two different strategies to initiate red
blood cells transfusions in patients with acute brain injury: a "liberal" strategy, which
aims to maintain hemoglobin(Hb) concentrations above 9 g/dL and a "restrictive" approach to
blood transfusion that maintains hemoglobin concentrations above 7 g/dL. Target population
includes patients suffering from traumatic brain injury (TBI), subarachnoid hemorrhage (SAH)
and intracranial hemorrhage (ICH). The primary outcome is neurological outcome, evaluated
using extended Glasgow Outcome Scale (eGOS), at 180 days after the initial injury. Secondary
outcomes include, amongst all, 28-day survival, intensive care unit (ICU) and hospital
length of stay, the occurrence of extra-cerebral organ dysfunction/failure and the
development of any infection or thromboembolic events (either venous or arterial). The
estimated sample size to demonstrate a reduction in the primary outcome between groups from
50% to 45% is 4610 patients (2305 for each arm). The study will be initiated in 2015 within
several European ICUs and conducted over 4 years.
Expected outcomes/Discussion: This trial will assess the impact of two different strategies
to administer blood transfusions in a large cohort of critically ill patients with a primary
brain injury. The results of this trial may help to better manage blood products and
transfusion thresholds in this specific patients‟ population and will provide additional
data in some sub-groups of patients at high-risk of brain ischemia, such as those with an
intracranial hypertension or developing cerebral vasospasm.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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