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TRansfusion Strategies in Acute Brain INjured Patients (TRAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968654
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : October 17, 2022
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Fabio Taccone, Erasme University Hospital

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

Condition or disease Intervention/treatment Phase
Acute Brain Injury Blood Transfusion Procedure: Restrictive Transfusion Strategy Procedure: Liberal Transfusion Strategy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 794 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfusion Strategies in Acute Brain Injured Patients. A Prospective Multicenter Randomized Study.
Actual Study Start Date : September 13, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Unfavorable Neurological Outcome [ Time Frame: 180 days after randomization ]
    Unfavorable neurological outcome is defined by the extended Glasgow Outcome Scale (eGOS) of 1-5


Secondary Outcome Measures :
  1. Survival [ Time Frame: 28 days ]
    28 days Survival

  2. 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

  3. ICU length of stay [ Time Frame: 180 days ]
    length of ICU stay

  4. Hospital length of stay [ Time Frame: 180 days ]
    length oh hospital stay

  5. Presence and severity of extra-cerebral organ dysfunction/failure [ Time Frame: 28 days ]
    Daily sequential organ failure assessment (SOFA) score

  6. Infection rate [ Time Frame: 28 days ]
    Occurrence of any infection over the first 28 days after randomization

  7. 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)

  8. 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

  9. Daily Fluid Balance [ Time Frame: 28 days ]
    Assessment of the daily fluid balance

  10. Serious Adverse Events (SAE) [ Time Frame: 28 days ]
    Any of the "SAE" as described in the study protocol


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glasgow Coma Score (GCS) ≤ 13 on randomization
  • Expected ICU stay > 72 hours
  • hemoglobin (Hb) concentration ≤ 9 g/dL within 10 days from brain injury

Exclusion Criteria:

  1. Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative)
  2. Known previous neurological disease, causing significant cognitive and/or motor handicap
  3. ICH due to arterio-venous malformation (AVM) or brain tumor
  4. Inability (religious reasons) or reduced ability (lack of compatible blood) to receive blood products
  5. Active and uncontrolled bleeding at the time of enrollment
  6. GCS of 3 with both pupils fixed and dilated; brain death or imminent death (within 24 hours)
  7. Pregnancy
  8. Medical need to correct anemia (e.g., active coronary disease or severe cardiac disease) with target Hb levels > 9 g/dL
  9. do-not-escalate (DNE) orders
  10. Previous allo-immunization due to transfusion, limiting red blood cells (RBC) availability
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Fabio S TACCONE, MD, PhD +3225555587 ftaccone@ulb.ac.be
Contact: Dominique Durand +3225555580 ddurand@ulb.ac.be

Locations
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Belgium
Hopital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Fabio S Taccone, MD, PhD    +3225555587    ftaccone@ulb.ac.be   
Contact: Dominique Durand    +3225555580    ddurand@ulb.ac.be   
Sponsors and Collaborators
Erasme University Hospital
European Society of Intensive Care Medicine
More Information
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Responsible Party: Fabio Taccone, Professor, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT02968654    
Obsolete Identifiers: NCT02962349
Other Study ID Numbers: P2015/327
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fabio Taccone, Erasme University Hospital:
Blood Transfusion
Brain Injury
Outcome
Hemoglobin
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries