No registrations found.
ID
Source
Brief title
Health condition
Traumatic Brain Injury
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy: Therapy Intensity Level (TIL) scale and GOS-E at 6 months
Safety: Complication rate
Secondary outcome
- ICP burden
- CT scan midline shift
- Mortality
- Neurological damage markers in the blood using BANYAN biomarker assay
- Complement activity (WIESLAB, C3b/C, C4b/C, C5b-9 ELISA and CH50/AC50 essay)
- Gene expression profiling of blood cells
- ICU and hospital length of stay
- Ventilator days
- Hospital disposition
- GOS-E at 3 and 12 months
- QoLiBri at 3, 6 and 12 months
- SF 36 at 3, 6 and 12 months
- EQ-5D-5L at 3, 6 and 12 months
- Cost-effectiveness
Background 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. Therefore, this trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with s-TBI. 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.
Study objective
The hypothesis is that random assignment to C1-INH in patients with moderate and severe TBI will experience a reduction in ICP directed therapy intensity levels (TIL) compared to random assignment to placebo (difference of 2.2). Secondary, if efficacy is proven on the TIL scale, a difference of the GOSE at six months will be evaluated. Furthermore, no difference should be detected in complication rate during hospitalization between the two groups.
Study design
Hospital admission, hospital discharge, 3, 6 and 12 months follow-up
Intervention
(1) 6000 IU C1-INH intravenously
(2) Placebo 0.9% saline
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 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.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8387 |
| CCMO | NL72551.058.20 |
| OMON | NL-OMON52831 |