A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Recombinant Factor VIIa (NovoSeven®/Niastase®) with Brain Contusions.

ovo Nordisk A/S0 个研究点目标入组 96 人2004年6月22日

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注册库

who.int

开始日期

2004年6月22日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•1\. Informed consent obtained before any trial\-related activities. (Trial\-related activities are any procedure that would not have been performed during normal management of the subject). Signed informed consent may be obtained either from the subject and/or his/her legally acceptable representative (LAR).
•2\. Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset.
•3\. Head CT scan showing intraparencymal haemorrhage (one or more contusions) with a total minimum volume of greater than or equal to 2ml and at least one single intraparenchymal haemorrhage greater than or equal to 1ml as detected determined by the ABC/2 method.
•4\. Male or female subjects, age 18 years or over.
•5\.GCS between 4 and 14 (both inclusive) or if GCS cannot be assessed: a motor score of 2\-5 (both inclusive).
•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) yes

•1\. Life expectancy less than 24 hours after injury
•2\. Any planned surgery of parenchymal lesions in the brain within 24 hours of dosing
•3\. Time of CBI unknown or \> 6 hours prior to initial CT scan
•4\. Penetrating brain injury (e.g. gunshot wounds, stab wounds)
•5\. Body weight greater than or equal to 160 kg
•6\. Spinal cord injury
•7\. The following CT findings in isolation: pure subarachnoid haemorrhage, pure intra\-ventricular haemorrhage, pure epidural haemorrhage pure subdural haemorrhage or suspicion of a spontaneous intracerebral haemorrhage
•8\. Subjects with significant cardiovascular dysfunction or haemodynamic instability due to haemorrhage, e.g. systolic blood pressure ? 90 mmHg and/or red blood cell transfusion needed to maintain haemodynamic stability before the initial CT scan
•9\. Subjects scheduled to surgery or any other procedure that according to the judgement of the investigator will interfere with the planned study procedures
•10\. Subjects with known previous major cerebral diseases (traumatic or non\-traumatic) with permanent neurological deficits (i.e. subjects with a pre\-injury modified Rankin Score of 3 or higher)