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…
ID
Bron
Verkorte titel
Aandoening
Traumatic Brain Injury
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Efficacy: Therapy Intensity Level (TIL) scale and GOS-E at 6 months
Safety: Complication rate
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Hospital admission, hospital discharge, 3, 6 and 12 months follow-up
Onderzoeksproduct en/of interventie
(1) 6000 IU C1-INH intravenously
(2) Placebo 0.9% saline
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8387 |
| CCMO | NL72551.058.20 |
| OMON | NL-OMON52831 |