Complement Inhibition: Attacking the Overshooting Inflammation @fter Traumatic Brain Injury ( A phase II trial on the safety and efficacy of C1 esterase inhibitor Cinryze for the acute management of severe traumatic brain injury)
- Conditions
- Traumatic Brain Injury1002211410021666
- Registration Number
- NL-OMON52831
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 106
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age at admission >= 18 years;
- Clinical diagnosis of traumatic brain injury with GCS < 13 (with intra
cranial deviations);
- Catheter placement for monitoring and management of increased ICP for at
least 24 hours;
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on
admission;
- Not expected to survive more than 24 hours after admission;
- Brain death on arrival in the participating centres;
- Severe pre-trauma disability, defined as being dependent on other people;
- Known prior history of sensibility to blood products or Cinryze;
- Patients with a history of hereditary angioedema;
- Patients with a history of thrombosis
- Pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method