Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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 neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system is therefore considered to be a potentially important new treatment for TBI, as has been shown in animal studies. This trial aims to study the safety and efficacy of C1-inhibitor compared to placebo in TBI patients. By temporarily blocking the complement system we hypothesize limitation of secondary brain injury and more favourable clinical outcome for TBI patients due to a decrease in the posttraumatic neuroinflammatory response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Netherlands Brain Foundation; Takeda
• Treatments: Complement C1 Inhibitor Protein

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.