Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT07285733
Brief Summary:
Neurocritical care has become a distinct discipline within the field of intensive care medicine with a major focus on the treatment of patients with acute damage to the most complex organ of the human body, the brain. The main indications for acute neurocritical care concern aneurysmal Subarachnoid Hemorrhage (SAH) and severe Traumatic Brain Injury (TBI). These disease entities form a major health and socioeconomic problem as they afflict young patients and the rate of death and disability is high. The pathology and treatment of these patients is heterogeneous and complex. Despite advances in basic neuroscience which have increased our understanding of processes in the injured brain, approaches to management are largely unfocused and adhere to the concept of a 'one pill for everybody' approach. Novel monitoring technology and new neuroimaging techniques now offer opportunities for advancing the care for these patients to a more individualized targeted management.
In the period of 2010-2014, a prospective trial was conducted in the Antwerp University Hospital, including 50 patients with either SAH or TBI, who underwent extensive monitoring, known as "Individualized targeted management in neurocritical care".
In NEMO-RETRO, the investigators want to answer proposed and new research questions in retrospective analyses, using current insights and methodologies.
Objectives:
1. Cerebral blood flow monitoring
1. Investigate the effect of changes in therapy (nature/intensity) on Cerebral Blood Flow (CBF) measured by thermal diffusion flowmetry and Transcranial Doppler (TCD)
2. Determine the added value of continuous CBF monitoring for the early detection of vasospasm and ischaemia
2. Brain tissue oxygen tension
1. Investigate the effect of changes in therapy (nature/intensity) on cerebral oxygenation as measured by Brain Tissue Oxygen Tension (PTiO2)
2. Investigate the relation between PTiO2 and hemodynamic parameters such as CBF, CPP, and ICP
3. Systemic effects of brain specific therapy
1. Investigate the effects of brain-targeted therapy on cardiac output and lung function
2. Determine the relation of CBF to cardiac output, in particular following triple H therapy
4. Neuroimaging
1. Accurately document structural brain damage following TBI and SAH
2. Document vasospasm and quantify flow and perfusion
3. Quantify the degree of secondary ischaemic damage to the brain
4. Differentiate swelling from edema
5. Train and validate models to interpret neuroimaging
5. Outcome
1. Assess global functional outcome at 6 months post-injury
2. Assess health-related quality of life at 6 months after injury
6. Integrated approach analysis
1. Describe the effects of brain-targeted therapy on cerebral and systemic parameters
2. Define the added value of extended multimodality monitoring and advanced neuroimaging to detect vasospasm and secondary ischaemic damage, defined by markers of neuronal injury and cell death
3. Develop recommendations for individualized targeted management
Study:
NCT07285733
Study Brief:
Protocol Section:
NCT07285733