Boosting recovery through excitation of arousal and awareness in comatose patients (BREA2KTHROUGH)
Phase 1
- Conditions
- Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injuryTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-503617-30-01
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 384
Inclusion Criteria
Clinically unresponsive patients admitted to the ICU either with a traumatic or non-traumatic brain injury or a systemic medical or surgical condition causing non-medically induced coma, Unconsciousness is expected by the attending physicians to last for =3 days, Age =18 years
Exclusion Criteria
Continuous pharmacologically sedation, Expected survival <7 days, Lack of Danish or English language proficiency, Lack of next-of-kin consent, Residency outside of Denmark, Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method