ESTUDIO EXPLORATORIO EN FASE IIa PARA EVALUAR LA SEGURIDAD, TOLERANCIA, FARMACODINÁMICA Y FARMACOCINÉTICA DÉL FÁRMACO VAS203 EN PACIENTES CON TRAUMATISMO CRANEOENCEFÁLICO MODERADO Y GRAVE

• Conditions: esiones cerebrales traumáticas de moderadas a graves; MedDRA version: 9.1Level: LLTClassification code 10060690

• Registration Number: EUCTR2009-012338-56-ES
• Lead Sponsor: vasopharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-19
• Last Update Posted: 26 June 2012

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) more than or equal to 5 and that requires Intracranial pressure (ICP) monitoring

5. Catheter placement (intraventricular or intraparenchymal only) for monitoring and management of increased ICP

6. Microdialysis probe placement in penumbra zone or ipsilateral to contusion if focal (evaluated by computer tomography [CT])

7. Systolic blood pressure more than or equal to 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).

8. Known or CT scan evidence of pre-existing major cerebral damage.

9. Decompressive craniectomy, planned prior to randomization.

10. Polychromatic patients with Injury Severity Score > 25, or rhabdomyolysis.

11. Injuries to ascending aorta and/or carotid arteries.

12. serum creatinine values > 1.5 mg/dL.

13. estimated glomerular filtration rate (eGFR) < 60 ml/min by Modification of Diet in Renal Disease (MDRD) formula.

14. body mass index (BMI) > 35, Body weight > 120 kg.

15. Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission.

16. Known to have received an experimental drug within 4 weeks prior to current injury.

17. Administration of > 100 ml of contrast media containing iodine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified