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Advancing care for critically ill patients with acute traumatic brain injuries

BRAINapt – TBI International Adaptative Platform Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66884147
Enrollment
3000
Registered
2025-12-17
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury Injury, Occupational Diseases, Poisoning

Interventions

Current interventions as of 03/06/2026: Beta-Blockers Domain: Domain-Specific Exclusion Criteria: Contraindications to beta-blockers as per treating physician. Intervention Arms: Participants will be
enteral (PO or by feeding tube). Recommended initial daily dose 40 mg (10 mg q 6 h). Recommended target daily dose 80 mg (20 mg q 6 h). Recommended maximal daily dose 160 mg (40 mg q 6 h). Frequency:
enteral (PO or by feeding tube). Recommended initial daily dose 50 mg (25 mg q 12 h). Recommended target daily dose 100 mg (50 mg q 12 h). Recommended maximal daily dose 200 mg (100 mg q 12 h). Freque
pre-existing anticonvulsant therapy for seizure disorder
early seizure requiring anticonvulsants
more than 72 hours elapsed since ICU admission. Intervention Arms: Participants will be randomly a

Sponsors

Université Laval
Lead Sponsor
Centre de recherche du CHU de Québec-Université Laval
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged =18 years 2. Admitted to the intensive care unit following acute TBI 3. Moderate or severe acute TBI (GCS =12 [on a scale of 3 to 15]) Each domain may have additional inclusion criteria

Exclusion criteria

Exclusion criteria: Platform trial exclusion criteria: 1. A decision to withdraw life-sustaining therapies was made Domain exclusion criteria: Beta-blocker domain: 1. Contraindications to use beta-blockers based on clinical risk (as per treating physician) Anticonvulsant domain: 1. Contraindications to use anticonvulsants based on clinical risk (as per treating physician) 2. Patient on anticonvulsants for seizure disorder prior to hospital admission 3. Early seizure requiring anticonvulsants 4. More than 72 hours have elapsed since ICU admission

Countries

Australia, Belgium, Brazil, Canada, Colombia, France, Ireland, Italy, Netherlands, New Zealand, Switzerland

Contacts

Public ContactAlexis;Larissa Turgeon;Belardin

;

alexis.turgeon@crchudequebec.ulaval.ca;larissa.berloffa-belardin@crchudequebec.ulaval.ca+1 (0)418-525-4444 #64056;+1 (0)418-525-4444 #64145

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026