EFFICACY OF VAS203 IN PATIENTS WITH MODERATE AND SEVERETRAUMATIC BRAIN INJURY (NOSTRA Phase III trial)A confirmatory, placebo-controlled, randomised, double blind, multi-centre study.

Phase 1

• Conditions: Moderate and severe traumatic brain injury; MedDRA version: 18.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-003368-29-GB
• Lead Sponsor: vasopharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-30
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 232

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
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) < 60 mL/min as calculated by Chronic Kidney Disease Epidemiology Collaboration Formula
16.BMI < 18.5 kg/m2 and > 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

Study & Design

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