AN EXPLORATIVE PHASE IIa STUDY TO ASSESS SAFETY, TOLERABILITY,PHARMACODYNAMICS AND PHARMACOKINETICS OF VAS203 IN PATIENTS WITHMODERATE AND SEVERE TRAUMATIC BRAIN INJURY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 32

Inclusion Criteria

1. Written informed consent from patient’s legal guardian or legal representative,
according to local requirements
2. 18 - 65 years of age, inclusive
3. Head trauma within the last 12 hours
4. TBI with Glasgow Coma Score (GCS) = 5 and that requires Intracranial pressure
(ICP) monitoring - Cohort 1
4. TBI with Glasgow Coma Score (GCS) = 3 and that requires Intracranial pressure
(ICP) monitoring - Cohorts 2 & 3.
5. Catheter placement (intraventricular or intraparenchymal only) for monitoring and
management of increased ICP
6. Microdialysis probe placement in predominantly injured hemisphere ipsilateral to contusion if focal
(evaluated by computer tomography [CT])
7. Systolic blood pressure = 100 mmHg
8. Females of child-bearing potential must have a negative pregnancy test
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Penetrating head injury (e.g. missile, stab wound)
2. Not expected to survive more than 24 hours after admission
3. Concurrent, but not pre-existing, spinal cord injury
4. Unilateral and bilateral fixed and dilated pupil (> 4 mm)
5. Cardiopulmonary resuscitation performed post injury, or extracranial injuries causing continuing bleeding likely to require multiple transfusions (> 4 units red blood cells)
6. Coma due to a pure” epidural hematoma (lucid interval and absence of structural
brain damage on CT scan)
7. Coma suspected to be primarily due to other causes than head injury (e.g. drug
overdose - Cohort 1
7. Coma suspected to be primarily due to other causes than head injury (e.g. drug
overdose, alcohol intoxication, drowning/near drowning) - Cohorts 2 & 3
8. Known or CT scan evidence of pre-existing major cerebral damage
9. Decompressive craniectomy, planned prior to randomisation- Cohort 1
9. Decompressive craniectomy, planned prior to randomisation/enrolment - Cohort 2 & 3
10. Polytraumatic patients with Injury Severity Score > 25, or rhabdomyolysys. - Cohort 1
10. Polytraumatic patients with Injury Severity Score non head > 18 - Cohorts 2 & 3
11. Rhabdomyolysis with CK > 5000 IU/L - Cohorts 2 & 3
12. Injuries to ascending aorta and/or carotid arteries - Cohort 1
12. Injuries to ascending aorta and/or carotid arteries and/or vertebral arteries - Cohorts 2 & 3.
13. Serum creatinine values > 1.5 mg/dL (133 µmol/L)
14. Estimated glomerular filtration rate (eGFR) < 60 ml/min by Modification of Diet in
Renal Disease (MDRD) formula
15. Body mass index (BMI)> 35 kg/m2, Body > 120 kg - Cohort 1
15. Body mass index (BMI) < 19 kg/m2 and > 35 kg/m2, Body weight < 50 kg and > 120 kg - Cohorts 2 & 3.
16. Any severe concomitant condition (cancer; haematologic, renal, hepatic, coronary
disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
17. Known to have received an experimental drug within 4 weeks prior to current injury
18. Administration of > 100 ml of contrast media containing iodine

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

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