TRansfusion Strategies in Acute Brain INjured Patients
Condition: Acute Brain Injury; Blood Transfusion
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      To compare a "liberal" and a "restrictive" strategy to administer blood transfusions in
      critically ill patients with a primary brain injury.
    

Detailed description: 
      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 dealing with the optimal transfusion
      threshold. 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.

      This prospective, multicenter, randomized, pragmatic trial will compare 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 intracranial hemorrhage (ICH).

      The primary outcome is neurological outcome, evaluated using the extended Glasgow Outcome
      Scale (eGOS), at 180 days after the initial injury. Secondary outcomes include, amongst
      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 (venous or arterial).

      The estimated sample size is 794 patients to demonstrate a reduction in the primary outcome
      (i.e. unfavorable neurological outcome) from 50% to 30% between groups (397 patients in each
      arm). The study will be initiated in September 2016 in several European ICUs and is expected
      at least 6 years.

      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 sub-groups of patients
      at high-risk of brain ischemia, such as those with intracranial hypertension or cerebral
      vasospasm.
    

Intervention name(s): Restrictive Transfusion Strategy; Liberal Transfusion Strategy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be randomized when hemoglobin levels will be below 9 g/dl. Patients randomized to the "Restrictive Transfusion Strategy" will receive blood transfusion whenever their Hb concentration is < 7 g/dl. All patients should preferably receive one unit of blood transfusion at a time. The duration of the intervention is 28 days after randomization or until hospital discharge. Daily assessment of hemoglobin levels are mandatory only during the ICU stay. No other procedures and or interventions are scheduled. General management of patients will be conducted according to international guidelines; however, local protocols and procedures are allowed.; Patients will be randomized when hemoglobin levels will be below 9 g/dl. Patients randomized to the "Liberal Transfusion Strategy" will receive blood transfusion whenever their Hb concentration is < 7 g/dl. All patients should preferably receive one unit of blood transfusion at a time. The duration of the intervention is 28 days after randomization or until hospital discharge. Daily assessment of hemoglobin levels are mandatory only during the ICU stay. No other procedures and or interventions are scheduled. General management of patients will be conducted according to international guidelines; however, local protocols and procedures are allowed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood Transfusion; Brain Injury; Outcome; Hemoglobin