NCT02968654

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
850

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

6.3 years

First QC Date

November 11, 2016

Last Update Submit

September 5, 2023

Conditions

Acute Brain InjuryBlood Transfusion

Keywords

Blood TransfusionBrain InjuryOutcomeHemoglobin

Outcome Measures

Primary Outcomes (1)

  • Unfavorable Neurological Outcome

    Unfavorable neurological outcome is defined by the extended Glasgow Outcome Scale (eGOS) of 1-5

    180 days after randomization

Secondary Outcomes (10)

  • Survival

    28 days

  • Changes in the Glasgow Coma Score (GCS) over time

    28 days

  • ICU length of stay

    180 days

  • Hospital length of stay

    180 days

  • Presence and severity of extra-cerebral organ dysfunction/failure

    28 days

  • +5 more secondary outcomes

Study Arms (2)

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)

Procedure: Restrictive Transfusion Strategy

Liberal Transfusion Strategy

OTHER

"Blood Transfusion" will be given when hemoglobin concentration will be below 9 g/dL

Procedure: Liberal Transfusion Strategy

Interventions

Restrictive Transfusion StrategyPROCEDURE

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.

Restrictive Transfusion Strategy
Liberal Transfusion StrategyPROCEDURE

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.

Liberal Transfusion Strategy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Erasme

Brussels, 1070, Belgium

Location

Related Publications (3)

  • Taleb 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.

    PMID: 39920710DERIVED

  • Taccone 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.

    PMID: 39382241DERIVED

  • Taccone 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.

    PMID: 36611210DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 18, 2016

Study Start

September 13, 2016

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)