Traumatic Brain Injury
Conditions
Interventions
(1) 6000 IU C1-INH intravenously
(2) Placebo 0.9% saline
Sponsors
Leiden University Medical Center
Eligibility
Inclusion 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Therapy Intensity Level (TIL) scale and GOS-E at 6 months Safety: Complication rate | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 | — |
Contacts
Public ContactInge van Erp
Leiden University Medical Center
Outcome results
None listed