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Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

NCT number NCT02962349
Study type Interventional
Source European Society of Intensive Care Medicine
Contact Fabio S TACCONE, MD, PhD
Phone +3225555587
Status Recruiting
Phase N/A
Start date September 2016
Completion date December 2020

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