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Trauma, Brain clinical trials

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NCT ID: NCT06083441 Recruiting - Clinical trials for Traumatic Brain Injury

SeeMe: An Automated Tool to Detect Early Recovery After Brain Injury

Start date: June 16, 2019
Phase:
Study type: Observational

Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, "SeeMe," to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.

NCT ID: NCT06057155 Not yet recruiting - Stroke, Ischemic Clinical Trials

Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle

CLOSED
Start date: May 1, 2024
Phase:
Study type: Observational

The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle. Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.

NCT ID: NCT06028906 Recruiting - Trauma, Brain Clinical Trials

Research of Optimal Cerebral Perfusion Pressure Diagnosis

optCPP
Start date: June 21, 2021
Phase:
Study type: Observational

The research will investigate the hypothesis that timely identification of the optimal value of the cerebral perfusion pressure (optCPP) or optimal arterial blood pressure (optABP) is possible after detecting informative episodes of arterial blood pressure (ABP) that reflects the physiological autoregulatory reactions of the cerebral blood flow, This biomedical study will be conducted to test this hypothesis and to develop an algorithm for identification of optimal brain perfusion pressure within limited time (several tens of minutes). The goal of this observational study is to test the method of timely optimal cerebral perfusion pressure value or optimal arterial pressure value in intensive care patients after brain surgery. The main question it aims to answer are: how long it takes to identify optimal cerebral perfusion value when arterial blood pressure is changing within safe physiological limits. Objectives of the study 1. To perform a prospective observational study by collecting multimodal physiological brain monitoring data: intracranial pressure (ICP), arterial blood pressure (ABP), End-tidal carbon dioxide (ETCO2), cerebral blood flow velocity (CBFV), ECG. 2. To perform a retrospective analysis of the accumulated clinical monitoring data, in order to create an algorithm for the identification of informative monitoring data fragments, according to which it would be possible to identify the optimal cerebral perfusion pressure (optCPP) value in a limited time interval (within a few or a dozen minutes). 3. To perform a retrospective analysis of accumulated clinical monitoring data, determining correlations of cerebral blood flow autoregulation and optCPP-related parameters with the clinical outcome of patients and with the risk of cerebral vasospasm or cerebral ischemia.

NCT ID: NCT06027411 Recruiting - Stroke, Ischemic Clinical Trials

Assess the Clinical Effectiveness in AI Prioritising CT Heads

ACCEPT
Start date: March 27, 2024
Phase:
Study type: Observational [Patient Registry]

Non-Contrast Computed Tomography (NCCT) of the head is the most common imaging method used to assess patients attending the Emergency Department (ED) with a wide range of significant neurological presentations including trauma, stroke, seizure and reduced consciousness. Rapid review of the images supports clinical decision-making including treatment and onward referral. Radiologists, those reporting scans, often have significant backlogs and are unable to prioritise abnormal images of patients with time critical abnormalities. Similarly, identification of normal scans would support patient turnover in ED with significant waits and pressure on resources. To address this problem, Qure.AI has worked to develop the market approved qER algorithm, which is a software program that can analyse CT head to identify presence of abnormalities supporting workflow prioritisation. This study will trial the software in 4 NHS hospitals across the UK to evaluate the ability of the software to reduce the turnaround time of reporting scans with abnormalities that need to be prioritised.

NCT ID: NCT05855252 Recruiting - Trauma, Brain Clinical Trials

PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury

Start date: August 14, 2022
Phase:
Study type: Observational

Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.

NCT ID: NCT05818371 Not yet recruiting - Clinical trials for Subarachnoid Hemorrhage

Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting

ONSDDynamics
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.

NCT ID: NCT05726201 Recruiting - Trauma, Brain Clinical Trials

(POCUS) As an Early Screening Tool for Diagnosing Skull Fractures in Children

Start date: July 23, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate the accuracy of POCUS as a screening tool for early diagnosis of skull fractures in children with mild closed head injuries admitted to the emergency department. The results would aid the emergency physicians to speed up the management and reduce the cost of diagnosing skull fractures and TBI.

NCT ID: NCT05441618 Enrolling by invitation - Trauma, Brain Clinical Trials

Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®

LYOPLACE
Start date: April 2, 2024
Phase:
Study type: Observational

Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.

NCT ID: NCT05307640 Recruiting - Trauma, Brain Clinical Trials

Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries

CG-Well
Start date: August 16, 2021
Phase: N/A
Study type: Interventional

After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.

NCT ID: NCT05195996 Completed - Trauma, Brain Clinical Trials

Beta Blocker Effects in Traumatic Brain Injury

Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

The study will be conducted on polytrauma patient who are admitted from emergency room or postoperative with head trauma to evaluate effects of beta blocker on patients with TBI.