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

Traumatic Brain Injury Clinical Trial

Official title:
A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Severe Traumatic Brain Injury

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04489160
Study type Interventional
Source Leiden University Medical Center
Contact Inge van Erp, BSc
Phone +31(0)715262109
Email i.a.m.van_erp@lumc.nl
Status Recruiting
Phase Phase 2
Start date February 25, 2021
Completion date July 2024
View Details
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