Moderate and severe traumatic brain injury MedDRA version: 20.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury System Organ Class: 100000004863
Conditions
Interventions
Product Name: VAS203
Product Code: VAS203
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: Ronopterin
CAS Number: 206885-38-3
Current Sponsor code: VAS203
Other descrip
Sponsors
vasopharm GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Written informed consent from patient’s legal guardian or legal representative or deferred consent procedure, according to local requirements 2. 18 - 60 years of age, inclusive 3. Expected to survive more than 24 hours after admission 4. Traumatic Brain Injury (TBI) within the last 18 hours (infusion must not start earlier than 6 hours after the injury) 5. TBI with Glasgow Coma Score (GCS) = 3 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician. 6. Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP 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 232 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Penetrating head injury (e.g. missile, stab wound) 2. Concurrent, but not pre-existing, spinal cord injury 3. Bilateral fixed and dilated pupil (> 4 mm). However, inclusion with unilateral fixed and dilated pupil (> 4 mm) is possible when there are no signs of herniation in transtentorial or temporal brain area. 4. Cardiopulmonary resuscitation performed post injury, or extracranial injuries causing continuing bleeding likely to require multiple transfusions (> 4 units red blood cells) 5. Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan) 6. Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning) 7. Known or CT scan evidence of pre-existing major cerebral damage 8. Patients who cannot be monitored with regard to their recovery (eGOS-I and QOLIBRI) 9. Patients and relatives of patients who don´t understand/speak Spanish, or English, or French, or German (if Israel is included: Hebrew, Russian, Arabic). 10. Decompressive craniectomy, planned prior to randomisation Note:enrolment is possible, when osteoplastic craniectomy is performed for hematoma evacuation, only 11. Polytraumatic patients with Injury Severity Score non-head > 18 12. Rhabdomyolysis with CK > 5000 IU/L 13. Injuries to ascending aorta and/or carotid arteries and vertebral arteries 14. Serum creatinine values > 1.2 mg/dL (106 µmol/L) (women), or > 1.5 mg/dL (133 µmol/L) (men) 15. Estimated glomerular filtration rate (eGFR) 40 kg/m2, Body weight > 110 kg 17. Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission 18. Known to have received an experimental drug within 4 weeks prior to current injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate efficacy of VAS203 on clinical outcome at 6 months (extended Glasgow Outcome Scale Interview, eGOS-I) in patients suffering from moderate and severe traumatic brain injury (TBI) ;Secondary Objective: To demonstrate efficacy on • Quality of Life after Brain Injury (QOLIBRI) at 6 months after TBI • QOLIBRI overall scale (QOLIBRI-OS) at 6 months after TBI • eGOS-I at 3 months after TBI • QOLIBRI-OS at 3 months after TBI • 24-hours value of Therapy Intensity Level (TIL) over 14 days after start of treatment • number of craniectomies (one or both hemispheres) ;Primary end point(s): Clinical outcome eGOS-I at 6 months after the TBI will be evaluated face to face with the patient and or a proxy by means of a standardized questionnaire in an interview ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy assessments • QOLIBRI at 6 months after the TBI will be evaluated face to face with the patient and or a proxy by means of a standardized questionnaire in an interview form • QOLIBRI OS at 6 months after TBI will be evaluated face to face with the patient or a proxy by means of a standardized questionnaire in an interview form (Appendix z) • eGOS-I at 3 months after TBI will be evaluated face to face with the patient and/or a proxy by means of a standardized questionnaire in an interview form (Appendix x) • QOLIBRI OS at 3 months after TBI will be evaluated face to face with the patient or a proxy by means of a standardized questionnaire in an interview form (Appendix z) • 24-hours value of TIL on a daily base over 14 days after start of treatment • Number of decompressive craniectomies (one or both hemispheres) ;Timepoint(s) of evaluation of this end point: 14 days, 3 months and 6 months | — |
Countries
Austria, France, Germany, Spain, United Kingdom
Contacts
Public ContactFrank Tegtmeier
vasopharm GmbH
Outcome results
None listed