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Brain Edema clinical trials

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NCT ID: NCT05725694 Enrolling by invitation - Clinical trials for Acute Ischemic Stroke

Acute Ischaemic STROKE: From LAboratory to the Patient's BED

STROKELABED
Start date: October 1, 2015
Phase:
Study type: Observational

Background: Recanalization strategies have radically changed the outcome in a significant part of stroke patients. The unpredictable occurrence of cerebral edema (CE) and hemorrhagic transformation (HT) are frequent events in patients affected by ischemic stroke, even when an effective vessel recanalization has been achieved. These complications, related with blood brain barrier (BBB) disruption, remain difficult to prevent or treat, and antagonize the beneficial effect of successful recanalization, leading to poor outcome. Aim: to shed light on the reperfusion injury biological bases, this study aims at evaluating the effects of circulating and imaging biomarkers in relation to CE and HT both in stroke patients and in a coherent murine stroke model. A close interaction between clinical and preclinical research could lead to a broader understanding of the results deriving from the individual lines of activity, allowing a deeper interpretation of the underlying phenomena. Methods: The clinical setting is a retrospective observational study enrolling consecutive patients with acute ischemic stroke in the anterior circulation territory, treated with reperfusion therapies, at Careggi University Hospital in Florence (Italy) from October 1, 2015 to May 31, 2020. In this cohort, the investigators will apply a new approach to assess the presence of CE and HT after stroke in CT scans, through the quantification of anatomical distortion (AD) (induced by fluid extravasation in brain tissue) at 24 hours. A large panel of blood biomarkers related to inflammation, endothelial dysfunction , and fibrin resistance to lysis, will be measured as blood samples are taken from each patient before and 24 hours after thrombolysis or thrombectomy. The role of both AD and blood biomarkers as predictors of 3 months functional outcome, assessed by modified Rankin Scale (mRS), will be estimated. Using a translational approach the investigators will develop a new mouse model of light-induced occlusion/reperfusion of the middle cerebral artery (MCA) to better reproduce the human setting. Then, the investigators will assess functional impairment induced by stroke with and without recanalization at different time points and the investigators will assess through ex vivo experiments the insurgence of BBB alterations 24 hours after the lesion. Finally, the investigators will characterize the stroke volume and the inflammation one week after stroke.

NCT ID: NCT05714735 Active, not recruiting - Arterial Aneurysm Clinical Trials

SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm

SMCV
Start date: November 1, 2017
Phase:
Study type: Observational [Patient Registry]

Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations

NCT ID: NCT05696639 Active, not recruiting - Clinical trials for Subarachnoid Hemorrhage

SMCV Assessment on Brain Swelling in Patients With SAH

Bayysmcv
Start date: April 1, 2017
Phase:
Study type: Observational

Cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.This study is a retrospective cohort aimed to predict the extent of brain swelling. Cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.

NCT ID: NCT05690711 Not yet recruiting - Clinical trials for Brain Swelling, Large Hemispheric Infarction

A Trial of HRS8179 on Brain Swelling After Large Hemispheric Infarction

Start date: February 15, 2023
Phase: Phase 2
Study type: Interventional

The primary objective is to explore if HRS8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. The secondary objective is to explore if HRS8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.

NCT ID: NCT05622461 Recruiting - Clinical trials for Traumatic Brain Injury

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

NCT ID: NCT05593380 Not yet recruiting - Critical Care Clinical Trials

The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH

BIATICH
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Spontaneous cerebral hemorrhage (SICH) is a hemorrhage caused by the rupture of a blood vessel within the brain parenchyma that is non-traumatic. Its rapid onset and dangerous condition seriously threaten human health; it accounts for about 15% of strokes and 50% of stroke-related mortality. Hunan Province is recognized as one of the high incidence areas of cerebral hemorrhage in the world; according to statistics, the direct economic loss caused by cerebral hemorrhage in Hunan Province is more than 1 billion yuan per year, which should be paid great attention. A 30-day follow-up study of large-volume cerebral hemorrhage (defined as supratentorial hemorrhage greater than 30 ml, infratentorial greater than 5 ml, and thalamus and cerebellum greater than 15 ml) found that the morbidity and mortality rate of ICH with hemorrhage of 30-60 ml was as high as 44-74%, while the morbidity and mortality rate of ICH with hemorrhage of <30 ml was 19% and that of >60 ml was 91%. According to studies, the occurrence of hematoma occupancy and malignant cerebral edema in large-volume cerebral hemorrhage can lead to secondary malignant intracranial pressure elevation and subsequent secondary brain injury, which are the main factors of high morbidity and mortality and poor prognosis in patients with large-volume cerebral hemorrhage. Clinical monitoring and management is the key to treatment, and despite aggressive surgical treatment and anti-brain edema therapy, a large number of patients progress to malignant brain edema disease, leading to poor outcomes. Therefore, this project intends to conduct a multicenter clinical trial of non-invasive monitoring of large volume cerebral hemorrhage on the curtain in the Hunan region to explore the impact of non-invasive brain edema monitoring management based on bioelectrical impedance technology on patient prognosis; and to explore early biomarkers of malignant brain edema through metabolomic analysis and the mechanism of malignant brain edema occurrence through multi-omic analysis to provide data support for the clinical treatment application of malignant brain edema.

NCT ID: NCT05585255 Recruiting - Clinical trials for Ischemic Stroke, Acute

Clinical Significance of DKK2 Protein in Cerebral Ischemia-reperfusion Injury

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

The study is a two-center prospective cohort clinical trial. The primary purpose of this trial is to identify the pattern of DKK2 serum levels in ischemic stroke patients after revascularization therapy and determine the correlation between serum DKK2 levels and prognosis.

NCT ID: NCT05200728 Completed - Clinical trials for Acute Ischemic Stroke

The Tolerability, Safety, and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers

Start date: December 6, 2021
Phase: Phase 1
Study type: Interventional

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the tolerability, safety, and pharmacokinetic characteristics of SIM1910-09 for injection after single/multiple dosing in healthy Chinese adult volunteers.

NCT ID: NCT05170295 Completed - Clinical trials for Intracranial Pressure Increase

Noninvasive Monitoring of Cerebral Blood Flow Autoregulation

Start date: April 18, 2018
Phase:
Study type: Observational

Rheoencephalography (REG) shows promise as a method for noninvasive neuromonitoring, because it reflects cerebrovascular reactivity. This protocol will study clinical and technical conditions required to use REG. Additionally, our goal is to study noninvasive peripheral bioimpedance pulse waveforms in order to substitute invasive SAP. A previous study demonstrated that REG can be used to detect spreading depolarization (SD), the early sign of brain metabolic disturbance. SD can be measured invasively with DC EEG amplifiers only. Our goal is to create an automatic notification function for REG monitoring indicating change of clinical conditions.

NCT ID: NCT05070182 Completed - Brain Injuries Clinical Trials

Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)

SERENADE
Start date: June 1, 2018
Phase:
Study type: Observational

The study will examine the resting energy need (REE) in patients suffering from brain damage. For the measurement of REE will be used a metabolic computer (which with continuous recording of breath-to-breath volume (Vt), respiratory rate (RR) of ventilation per minute volume (MV) ), of inhaled and exhaled gases (O2 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ.