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Intracranial Hemorrhages clinical trials

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NCT ID: NCT06081283 Recruiting - Stroke Clinical Trials

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Start date: November 20, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe acute brain injury patients with suppression of consciousness. The main questions it aims to answer are: - Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population? - What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity? Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

NCT ID: NCT06036732 Not yet recruiting - Clinical trials for Traumatic Brain Injury

A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score

Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

1. The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients. 2. The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores

NCT ID: NCT06032819 Not yet recruiting - Ischemic Stroke Clinical Trials

Differentiating Between Brain Hemorrhage and Contrast

Start date: September 2023
Phase:
Study type: Observational

The goal of this observational study is to use artificial intelligence to differentiate cerebral hemorrhage from contrast agent extravasation after mechanical revascularization in ischemic stroke. The main question it aims to answer is: Whether artificial intelligence can help differentiate brain hemorrhage from contrast agent extravasation. Patients with intracranial high-density lesions on CT scans within 24h after mechanical revascularization will be included. Expected to enroll 500 patients. The type of high-density lesion is determined according to dual-energy CT images or follow-up images. Patients will be divided into training group, validation and testing groups by stratified random sampling (6:2:2). After the images and the image labels are obtained, deep learning artificial intelligence will be used to learn the image characteristics and establish a diagnostic model, and the model performance and generalization ability will be evaluated.

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: NCT06018545 Active, not recruiting - Clinical trials for Acute Ischemic Stroke

AI Assisted Reader Evaluation in Acute Computed Tomography (CT) Head Interpretation

AI-REACT
Start date: June 1, 2023
Phase:
Study type: Observational

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). The purpose of the study is to assess the impact of an Artificial Intelligence (AI) tool called qER 2.0 EU on the performance of readers, including general radiologists, emergency medicine clinicians, and radiographers, in interpreting non-contrast CT head scans. The study aims to evaluate the changes in accuracy, review time, and diagnostic confidence when using the AI tool. It also seeks to provide evidence on the diagnostic performance of the AI tool and its potential to improve efficiency and patient care in the context of the National Health Service (NHS). The study will use a dataset of 150 CT head scans, including both control cases and abnormal cases with specific abnormalities. The results of this study will inform larger follow-up studies in real-life Emergency Department (ED) settings.

NCT ID: NCT05975398 Recruiting - Complications Clinical Trials

China Research for Severe Spontaneous Intracerebral Hemorrhage(CRISIH)

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

Background: Despite the capability of emergency surgery to reduce the mortality of severe spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients on LOAPT. Methods: As a multicenter and prospective cohort study, it will be conducted across 7 representative clinical centers. Starting in September 2019, the observation is scheduled to be completed by December 2022, with a total of 450 SSICH patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 6 months after the occurrence of primary hemorrhage. Study Design: In this study, two comparative cohorts and an observational cohort will be set up. The primary outcome is the effect of emergency surgery, which is subject to assessment using the total mortality and comparison in the survival rate of SSICH patients on LOAPT between surgical treatment and conservative treatment. The second outcome is the safety of surgery, with the postoperative hemorrhagic complication which is compared between the operated SSICH patients on and not on LOAPT. Based on the observation of the characteristics and outcome of SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further addressed, and the coagulation function assessment system for operated SSICH patients on LOAPT will be established. Objective: In this study, investigators will estimate the effect and safety of emergency surgery for SSICH patients on LOAPT, which will provide an evidence for management in the future.

NCT ID: NCT05968053 Recruiting - Glioma Clinical Trials

Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)

DT-MiNi
Start date: September 25, 2023
Phase:
Study type: Observational

Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids. Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients. The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.

NCT ID: NCT05920473 Recruiting - Clinical trials for Intracerebral Hemorrhage

Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).

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

This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.

NCT ID: NCT05874050 Recruiting - Blood Pressure Clinical Trials

Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.

HemoStopArt
Start date: November 11, 2022
Phase:
Study type: Observational

The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows: 1. Does an increase in systolic arterial pressure prompt a hemostatic maneuver by the neurosurgeon, and does the concomitant mean arterial pressure value influence the frequency of such interventions? 2. How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value? Participants will be enrolled during the preoperative evaluation, where their arterial pressure values, medical histories, and medication statuses will be recorded. Throughout the induction and maintenance of anesthesia, we will monitor their blood pressure values and document any instances of hypotension or hypertension. During the hemostatic phase, we will elevate the arterial pressure using noradrenaline by up to 10 mmHg above the recorded pressure measured at the inpatient clinic. Subsequently, we will inquire whether the neurosurgeon had to employ any additional hemostatic maneuvers following the increase in arterial pressure. The arterial pressure values will be recorded at the end of the surgery, and the first postoperative CT scan will be examined to identify any cases of intracranial hemorrhage.

NCT ID: NCT05871528 Recruiting - Ischemic Stroke Clinical Trials

Registry of Patients With Remote Posterior cErebral Hemorrhage Following Reperfusion Treatment in Ischemic Stroke

HEROES-CAT
Start date: May 1, 2021
Phase:
Study type: Observational

Introduction Remote cerebral hemorrhage following reperfusion treatment in ischemic stroke is rare (1.3-3.7% of all treated strokes) and is associated with worse functional and vital prognosis. Multicenter observational studies suggest that amyloid angiopathy may be one of the main risk factors for remote hemorrhage. Currently, it is unknown what happens to those patients with remote hemorrhage beyond 3 months of follow-up in terms of risk/benefit balance when receiving antiplatelet or anticoagulant therapy, as well as from a cognitive point of view. Considering an analogy with amyloid angiopathy, the hypothesis is that those patients with remote hemorrhage have a higher risk of intracranial hemorrhage during follow-up when receiving stroke secondary prevention, and will also present greater cognitive deterioration during long-term follow-up. Main Objectives - To explore the frequency and risk factors for intracranial hemorrhage during follow-up of patients with remote cerebral hemorrhage. - To explore the frequency and progression of cognitive deterioration during follow-up in patients with remote cerebral hemorrhage. Methodology Observational, prospective, multicenter registry with a population-based case-control design of consecutive patients with remote hemorrhage following reperfusion therapy in acute ischemic stroke. Inclusion criteria: Diagnosis of ischemic stroke with age greater than or equal to 18 years who has remote cerebral hemorrhage after receiving reperfusion therapy in the acute phase. Exclusion criteria: Lack of basic data (age, sex, neuroimaging data) or telephone for follow-up. The cases will be those patients with remote hemorrhage. For each case included, 4 consecutive controls will be included (2 with local parenchymal hemorrhagic transformation and 2 without hemorrhagic transformation). The data will be filled out within the (Codi Ictus de CATalunya) CICAT registry form (currently mandatory in all stroke centers in Catalonia) to which additional variables will be added. Telephone follow-up will be conducted at 3, 12, and 24 months. Main study variable: - Any type of spontaneous or traumatic intracranial hemorrhage during a 24-month follow-up. - Score on the "Short Informant Questionnaire" scale (a validated 17-question questionnaire to be conducted over the phone, where a score higher than 57 points indicates cognitive impairment). Expected sample size during a 2-year recruitment period: 105-300 patients (considering the participating centers to date). Additional information. This study is endorsed by the "Pla Director de la Malaltia Vascular Cerebral" in Catalonia. Participating Centers. Participation offers have been sent to the 28 hospitals in the hospital network of Catalonia with the capacity to administer intravenous fibrinolysis. Positive responses have been received from 13 of them so far. In case the project is accepted by the (Comité Ético de Investigación Clínica) CEIC Sant Pau, the centers that have not responded will be contacted again to obtain their participation.