TRansfusion Strategies in Acute Brain INjured Patients (TRAIN)
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|ClinicalTrials.gov Identifier: NCT02968654|
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : April 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Brain Injury Blood Transfusion||Procedure: Restrictive Transfusion Strategy Procedure: Liberal Transfusion Strategy||Not Applicable|
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 1000 patients to demonstrate a reduction in the primary outcome from 50% to 40% between groups (500 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transfusion Strategies in Acute Brain Injured Patients. A Prospective Multicenter Randomized Study.|
|Study Start Date :||September 13, 2016|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||July 30, 2023|
Restrictive Transfusion Strategy
"Blood Transfusion" will be given when hemoglobin concentration will be below 7 g/dL (as suggested by current guidelines in "general" ICU population)
Procedure: Restrictive Transfusion Strategy
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.
Liberal Transfusion Strategy
"Blood Transfusion" will be given when hemoglobin concentration will be below 9 g/dL
Procedure: Liberal Transfusion Strategy
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.
- Good Neurological Outcome [ Time Frame: 180 days after randomization ]Good neurological outcome is defined by the extended Glasgow Outcome Scale (eGOS) of 6-8
- Survival [ Time Frame: 28 days ]28 days Survival
- Changes in the Glasgow Coma Score (GCS) over time [ Time Frame: 28 days ]modification of GCS from admission over the first week and vs. the last available
- ICU length of stay [ Time Frame: 180 days ]length of ICU stay
- Hospital length of stay [ Time Frame: 180 days ]length oh hospital stay
- Presence and severity of extra-cerebral organ dysfunction/failure [ Time Frame: 28 days ]Daily sequential organ failure assessment (SOFA) score
- Infection rate [ Time Frame: 28 days ]Occurrence of any infection over the first 28 days after randomization
- Composite outcome [ Time Frame: 28 days ]Death and Organ Failure (defined as at least one extra-cerebral organ failure, according to the specific SOFA sub-score > 2)
- Brain Oxygen Pressure [ Time Frame: 28 days ]Absolute values of brain oxygen pressure (PbO2) for those patients where this neuromonitoring has been implemented, according to the decision of the attending physician
- Daily Fluid Balance [ Time Frame: 28 days ]Assessment of the daily fluid balance
- Serious Adverse Events (SAE) [ Time Frame: 28 days ]Any of the "SAE" as described in the study protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968654
|Contact: Fabio S TACCONE, MD, PhDfirstname.lastname@example.org|
|Contact: Dominique Durandemail@example.com|