Status:
UNKNOWN
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Netherlands Brain Foundation
Takeda
Conditions:
Traumatic Brain Injury
Trauma, Head
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
Severe Traumatic Brain Injury (s-TBI) is a major cause of death and disability across all ages. Besides the primary impact, the pathophysiologic process of major secondary brain damage consists of a n...
Eligibility Criteria
Inclusion
- Age at admission ≥ 18 years and \< 65 years;
- Clinical diagnosis of traumatic brain injury with GCS \< 13 (with intracranial deviations);
- Catheter placement for monitoring and management of increased ICP for at least 24 hours;
Exclusion
- 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 centers;
- 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.
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04489160
Start Date
February 25 2021
End Date
July 1 2024
Last Update
September 13 2021
Active Locations (3)
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1
Leiden University Medical Center
Leiden, Netherlands
2
Erasmus Medical Center
Rotterdam, Netherlands
3
Haaglanden Medisch Centrum
The Hague, Netherlands