Acute Brain InjuryTRAINNCT02968654
TRansfusion Strategies in Acute Brain INjured Patients
A study testing Restrictive Transfusion Strategy and Liberal Transfusion Strategy in people with Acute Brain Injury and Blood Transfusion, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
To compare a "liberal" and a "restrictive" strategy to administer blood transfusions in critically ill patients with a primary brain injury. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Brain Injury, Blood Transfusion
- What is being tested?
- Restrictive Transfusion Strategy and Liberal Transfusion Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Sep 2016to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma Score (GCS) ≤ 13 on randomization
- Expected ICU stay > 72 hours
- hemoglobin (Hb) concentration ≤ 9 g/dL within 10 days from brain injury
Who cannot join
- Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative)
- Known previous neurological disease, causing significant cognitive and/or motor handicap
- ICH due to arterio-venous malformation (AVM) or brain tumor
- Inability (religious reasons) or reduced ability (lack of compatible blood) to receive blood products
- Active and uncontrolled bleeding at the time of enrollment
- GCS of 3 with both pupils fixed and dilated; brain death or imminent death (within 24 hours)
Show all 10Show fewer
- Pregnancy
- Medical need to correct anemia (e.g., active coronary disease or severe cardiac disease) with target Hb levels > 9 g/dL
- do-not-escalate (DNE) orders
- Previous allo-immunization due to transfusion, limiting red blood cells (RBC) availability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfusion Strategies in Acute Brain Injured Patients. A Prospective Multicenter Randomized Study.
To compare a "liberal" and a "restrictive" strategy to administer blood transfusions in critically ill patients with a primary brain injury.
Read the 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.
- Conditions
- Acute Brain Injury, Blood Transfusion
- Being tested
- Restrictive Transfusion Strategy, Liberal Transfusion Strategy
- Keywords
- Blood Transfusion, Brain Injury, Outcome, Hemoglobin
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive Transfusion StrategyProcedure or surgery
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 StrategyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive Transfusion Strategy | Other | "Blood Transfusion" will be given when hemoglobin concentration will be below 7 g/dL (as suggested by current guidelines in "general" ICU population) Receives: Procedure: Restrictive Transfusion Strategy |
| Liberal Transfusion Strategy | Other | "Blood Transfusion" will be given when hemoglobin concentration will be below 9 g/dL Receives: Procedure: Liberal Transfusion Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unfavorable Neurological Outcome
Unfavorable neurological outcome is defined by the extended Glasgow Outcome Scale (eGOS) of 1-5
Measured: 180 days after randomization
Secondary outcomes (10)
Survival
28 days Survival
Measured: 28 days
Changes in the Glasgow Coma Score (GCS) over time
modification of GCS from admission over the first week and vs. the last available
Measured: 28 days
ICU length of stay
length of ICU stay
Measured: 180 days
Hospital length of stay
length oh hospital stay
Measured: 180 days
Presence and severity of extra-cerebral organ dysfunction/failure
Daily sequential organ failure assessment (SOFA) score
Measured: 28 days
Infection rate
Occurrence of any infection over the first 28 days after randomization
Measured: 28 days
Composite outcome
Death and Organ Failure (defined as at least one extra-cerebral organ failure, according to the specific SOFA sub-score > 2)
Measured: 28 days
Brain Oxygen Pressure
Absolute values of brain oxygen pressure (PbO2) for those patients where this neuromonitoring has been implemented, according to the decision of the attending physician
Measured: 28 days
Daily Fluid Balance
Assessment of the daily fluid balance
Measured: 28 days
Serious Adverse Events (SAE)
Any of the "SAE" as described in the study protocol
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start13 Sep 2016
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Fabio Taccone, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968654
- Sponsor's protocol ID
- P2015/327
- Acronym
- TRAIN
- Status last verified
- Sep 2023
- First submitted
- 11 Nov 2016
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zernini IS, Faso C, Rynkowski CB, Moller K, Lormans P, Diaz MQ, Caricato A, Beumier M, Voets E, Arias M, Quintard H, Morocho D, Kurtz P, Pognuz ER, Huet O, Mahmoodpoor A, Blandino-Ortiz A, Alcantara S, Chabanne R, Cicho F, Popugaev S, Giacomucci A, Dibu J, Cinotti R, Bouzat P, Vincent JL, Bogossian EG, Taccone FS; TRAIN Study Trial Group. Restrictive vs Liberal Transfusion Strategy in Traumatic Brain Injury: A Secondary Analysis of the TRAIN Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2632555. doi: 10.1001/jamanetworkopen.2026.32555.
PubMed 42709438Taleb C, Gouvea Bogossian E, Bittencour Rynkowski C, Moller K, Lormans P, Quintana Diaz M, Caricato A, Zattera L, Kurtz P, Meyfroidt G, Quintard H, Dias MC, Giacomucci A, Castelain C, Chabanne R, Marcos-Neira P, Bendel S, Alsheikhly AS, Elbahnasawy M, Gay S, D'Onofrio M, Popugaev KA, Markou N, Bouzat P, Vincent JL, Taccone FS; TRAIN Study Trial Group. Liberal versus restrictive transfusion strategies in subarachnoid hemorrhage: a secondary analysis of the TRAIN study. Crit Care. 2025 Feb 7;29(1):67. doi: 10.1186/s13054-025-05270-5.
PubMed 39920710Taccone FS, Rynkowski CB, Moller K, Lormans P, Quintana-Diaz M, Caricato A, Cardoso Ferreira MA, Badenes R, Kurtz P, Sondergaard CB, Colpaert K, Petterson L, Quintard H, Cinotti R, Gouvea Bogossian E, Righy C, Silva S, Roman-Pognuz E, Vandewaeter C, Lemke D, Huet O, Mahmoodpoor A, Blandino Ortiz A, van der Jagt M, Chabanne R, Videtta W, Bouzat P, Vincent JL; TRAIN Study Group. Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1623-1633. doi: 10.1001/jama.2024.20424.
PubMed 39382241Taccone FS, Badenes R, Rynkowski CB, Bouzat P, Caricato A, Kurtz P, Moller K, Diaz MQ, Van Der Jagt M, Videtta W, Vincent JL. TRansfusion strategies in Acute brain INjured patients (TRAIN): a prospective multicenter randomized interventional trial protocol. Trials. 2023 Jan 7;24(1):20. doi: 10.1186/s13063-022-07061-7.
PubMed 36611210
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Strategies in Acute Brain Injured Patients. A Prospective Multicenter Randomized Study.
- ClinicalTrials.gov ID
- NCT02968654
- Acronym / sponsor ID
- TRAIN / P2015/327
- Conditions
- Acute Brain Injury, Blood Transfusion
- Keywords
- Blood Transfusion, Brain Injury, Outcome, Hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive Transfusion Strategy | Other | Procedure: 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) |
| Liberal Transfusion Strategy | Other | Procedure: Liberal Transfusion Strategy"Blood Transfusion" will be given when hemoglobin concentration will be below 9 g/dL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Glasgow Coma Score (GCS) ≤ 13 on randomization
- Expected ICU stay > 72 hours
- hemoglobin (Hb) concentration ≤ 9 g/dL within 10 days from brain injury
Key exclusion criteria (10 listed)
- Post-anoxic coma; status epilepticus without underlying brain injury; central nervous system (CNS) infections (community-acquired; hospital-acquired; ventriculitis; post-operative)
- Known previous neurological disease, causing significant cognitive and/or motor handicap
- ICH due to arterio-venous malformation (AVM) or brain tumor
- Inability (religious reasons) or reduced ability (lack of compatible blood) to receive blood products
- Active and uncontrolled bleeding at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive Transfusion StrategyPatients 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. | Procedure or surgery | Restrictive Transfusion Strategy |
| Liberal Transfusion StrategyPatients 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. | Procedure or surgery | Liberal Transfusion Strategy |
Primary outcome
Unfavorable Neurological Outcome
Time frame: 180 days after randomization
Unfavorable neurological outcome is defined by the extended Glasgow Outcome Scale (eGOS) of 1-5
10 secondary outcomes
Survival
Time frame: 28 days
Changes in the Glasgow Coma Score (GCS) over time
Time frame: 28 days
ICU length of stay
Time frame: 180 days
Hospital length of stay
Time frame: 180 days
Presence and severity of extra-cerebral organ dysfunction/failure
Time frame: 28 days
Infection rate
Time frame: 28 days
Composite outcome
Time frame: 28 days
Brain Oxygen Pressure
Time frame: 28 days
Daily Fluid Balance
Time frame: 28 days
Serious Adverse Events (SAE)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 42709438Zernini IS, Faso C, Rynkowski CB, Moller K, Lormans P, Diaz MQ, Caricato A, Beumier M, Voets E, Arias M, Quintard H, Morocho D, Kurtz P, Pognuz ER, Huet O, Mahmoodpoor A, Blandino-Ortiz A, Alcantara S, Chabanne R, Cicho F, Popugaev S, Giacomucci A, Dibu J, Cinotti R, Bouzat P, Vincent JL, Bogossian EG, Taccone FS; TRAIN Study Trial Group. Restrictive vs Liberal Transfusion Strategy in Traumatic Brain Injury: A Secondary Analysis of the TRAIN Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2632555. doi: 10.1001/jamanetworkopen.2026.32555.
- Derived from this study: PubMed 39920710Taleb C, Gouvea Bogossian E, Bittencour Rynkowski C, Moller K, Lormans P, Quintana Diaz M, Caricato A, Zattera L, Kurtz P, Meyfroidt G, Quintard H, Dias MC, Giacomucci A, Castelain C, Chabanne R, Marcos-Neira P, Bendel S, Alsheikhly AS, Elbahnasawy M, Gay S, D'Onofrio M, Popugaev KA, Markou N, Bouzat P, Vincent JL, Taccone FS; TRAIN Study Trial Group. Liberal versus restrictive transfusion strategies in subarachnoid hemorrhage: a secondary analysis of the TRAIN study. Crit Care. 2025 Feb 7;29(1):67. doi: 10.1186/s13054-025-05270-5.
- Derived from this study: PubMed 39382241Taccone FS, Rynkowski CB, Moller K, Lormans P, Quintana-Diaz M, Caricato A, Cardoso Ferreira MA, Badenes R, Kurtz P, Sondergaard CB, Colpaert K, Petterson L, Quintard H, Cinotti R, Gouvea Bogossian E, Righy C, Silva S, Roman-Pognuz E, Vandewaeter C, Lemke D, Huet O, Mahmoodpoor A, Blandino Ortiz A, van der Jagt M, Chabanne R, Videtta W, Bouzat P, Vincent JL; TRAIN Study Group. Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1623-1633. doi: 10.1001/jama.2024.20424.
- Derived from this study: PubMed 36611210Taccone FS, Badenes R, Rynkowski CB, Bouzat P, Caricato A, Kurtz P, Moller K, Diaz MQ, Van Der Jagt M, Videtta W, Vincent JL. TRansfusion strategies in Acute brain INjured patients (TRAIN): a prospective multicenter randomized interventional trial protocol. Trials. 2023 Jan 7;24(1):20. doi: 10.1186/s13063-022-07061-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive Transfusion Strategy and Liberal Transfusion Strategy in people with Acute Brain Injury and Blood Transfusion, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unfavorable Neurological Outcome (time frame: 180 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968654, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.