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Trauma, Head clinical trials

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NCT ID: NCT04489160 Recruiting - Clinical trials for Traumatic Brain Injury

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

CIAO@TBI
Start date: February 25, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03721354 Recruiting - Trauma, Head Clinical Trials

Comparison Between NAVA and PSV in Neurocritical Patients

NAVAPSVHEAD
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration. During partially assisted ventilation, there is no predefined respiratory rate and the patient must trigger each breath. One of the most used partial assisted mode is pressure support ventilation (PSV), which plays a key role in weaning from mechanical ventilation, especially in neuro-cranial diseases. Neurally adjusted ventilatory assist mode (NAVA) has been introduced in clinical practice in recent years. It has been widely demonstrated that NAVA is able to guarantee gas exchange in the same way as PSV in patients admitted to ICU for respiratory failure. Thus, NAVA can improve patient-ventilator interaction reducing the incidence of asynchronous events and favoring the patient's own ventilatory pattern. Nevertheless, NAVA does not appear to have been applied in neuro ICU patients. In a study conducted on non-neurosurgical infants has been demonstrated negative effects of asynchronous events on cerebral blood flow velocities, examined with transcranial Doppler technique. In the present pilot study, the investigators would like to compare NAVA and PSV ventilation influence on cranial blood flow, evaluated with Trans-Cranial Color Doppler, in patients admitted to ICU for neurological injuries.