Intraventricular Hemorrhage and Post Hemorrhagic Ventricular Dilation: Natural Course, Treatment,...
Intraventricular HemorrhagePremature InfantsIntraventricular hemorrhage and its resultant post-hemorrhagic hydrocephalus are significant risk factors for the development of neurodevelopmental delays in preterm infants. The purpose of this study is to determine 1) the incidence of progressive post-hemorrhagic ventricular dilatation (PHVD) in infants with severe intraventricular hemorrhage (IVH), 2) the effect of ventricular dilatation on brain status (cerebral oxygenation, electrical activity, and biomarkers of cerebral damage and repair), and 3) if using ventricular measurements, derived from cranial ultrasound to guide removal of cerebral-spinal fluid through an Omaya reservoir, will help resolve ventricular dilatation and decrease the need for ventriculo-peritoneal (VP) shunt insertion. The hypothesis of this research project is that, by using ventricular measurements to guide the frequency of CSF removal, the rate of VP shunt insertion will be decreased in preterm infants with severe IVH and PHVD. The investigators further hypothesize that cerebral injury, as measured by cerebrospinal fluid (CSF) concentration of biomarkers of neuronal and glial damage and inflammation, will decrease over time with resolution of PHVD.
Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Intracerebral HemorrhageThe purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.
Safety of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke
Intracerebral HemorrhageThis study will determine if NXY-059 is safe in patients with an acute stroke caused by bleeding in the central nervous system. The primary objective was to assess the safety and tolerability of NXY-059 compared to placebo.
BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage
Intracerebral HaemorrhageThis trial will help inform the development of a new treatment for intracerebral haemorrhage (ICH; also known as haemorrhagic stroke). ICH is a type of stroke caused by spontaneous bleeding into the brain. In the hours to days after bleeding occurs, inflammation develops in the brain around the haematoma (collection of blood in the brain). Inflammation is the body's natural response to injury, however when it continues unchecked there is a risk that the brain tissue around the haematoma will become swollen. This type of swelling can worsen existing stroke symptoms or cause new deficits such as speech disturbance and limb weakness, which can lead to long term disability. The level of inflammation in the blood is high after ICH. The investigators want to investigate whether blocking this inflammation can improve overall recovery. The investigators research group has extensively investigated the use of a well-established anti-inflammatory drug, Kineret® in trials with patients who have suffered a stroke or brain haemorrhage. Kineret® is similar to a naturally-produced protein called interleukin-1 receptor antagonist (IL-1Ra) and is already licensed to treat patients with rheumatoid arthritis. The investigators have evidence from these previous studies that Kineret® reduced levels of inflammation in the blood after ischaemic stroke (caused by a blockage in an artery). However, in order to develop Kineret® as a treatment for ICH, the investigators need to know if it reduces levels of inflammation present in the blood following ICH and if it reduces swelling in the brain.
The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial...
Cerebral HemorrhageStroke9 moreContinued uncertainty exists over benefits of early intensive blood pressure (BP) lowering in acute intracerebral hemorrhage (ICH), related to the non-significant primary outcomes, patient selection, and discordant results of INTERACT2 and ATACH-II. We designed INTERACT3 to determine the effectiveness of a goal-directed care bundle of active management (intensive BP lowering, glycemic control, treatment of pyrexia and reversal of anticoagulation) vs. usual care in ICH. INTERACT3 is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute ICH.
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
Intracerebral HemorrhageCerebral Hemorrhage1 moreThis is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.
Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist
Intracerebral HemorrhageNovel, non-vitamin K antagonist oral anticoagulants (NOAC) target selected players in the coagulation cascade as the direct thrombin inhibitor dabigatran and the factor Xa-inhibitors apixaban and rivaroxaban. Intracerebral hemorrhage (ICH) is the most feared complication of NOAC treatment (NOAC-ICH). Outcome of NOAC-ICH can be devastating and is a major cause of death and disability. There is no proven treatment for NOAC-ICH. Hematoma expansion (HE) is associated with unfavorable outcome. Tranexamic acid (TA) is an anti-fibrinolytic drug that is used in a number of bleeding conditions other than ICH.
Neuropsychiatric Symptoms in Spontaneous Intracerebral Hemorrhage Survivors
Primary Disease or Condition Being Studiedor Focus of the StudyCompared to the United Kingdom and the United States, Spontaneous non-traumatic intracerebral hemorrhage (ICH) is more common among people in Taiwan. The prevalence rate of ICH was 14.0% for people aged 36 years or older in Taiwan. Primary ICH originates from the spontaneous rupture of small vessels damaged by chronic hypertension or cerebral amyloid angiopathy (CAA). Emotional disturbances are frequent symptoms in stroke survivors and negatively impact on functional recovery, the patient's quality of life and are distressing for both the patients and their caregivers. Furthermore, the emotional disturbances are associated with impaired cognitive. However, these issues are often unnoticed and most of the studies had been performed in ischemic stroke survivors rather than in patients with ICH. In this study, we will be recruited participants from National Taiwan University Hospital Bei-Hu branch and National Taiwan University Hospital. We aim to enroll respectively maximum number of 60 patients who had previous spontaneous ICH. Each participant will receive neuropsychiatric assessment, cognitive screening tests, domain-specific cognitive tests, a questionnaire for their quality of life and blood drawing for ApoE genotyping. The main aims of this study include (1) To investigate the prevalence of distinct neuropsychiatric symptoms in ICH survivors (2) To investigate the impact of non-cognitive neuropsychiatric issues on the cognitive functions and quality of life in ICH survivors. Our results may remind clinicians to pay more attention to the early diagnosis and effective management of neuropsychiatric symptoms to improve clinical outcomes.
Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage
Acute intraCerebral HaemorrhageHaemorrhagic strokes represent about 10-15 % of all strokes and 30,000 cases per year in France. The 30-day death rate ranges from 30 to 55% (50% of deaths occurring within 48 hours). Currently, no urgent medical or surgical treatment has been shown to improve functional or vital prognosis. Clinical epileptic seizures frequency in acute intracerebral haemorrhage has been estimated between 4% and 16% but the occurrence of subclinical epileptic seizures (detected on the electroencephalogram (EEG) only) could be much more frequent (28 % to 40 %). Some studies have suggested that early repeated epileptic seizures may be associated with a worse neurological prognosis. Repeated epileptic seizures occurring in the acute phase may increase brain oedema, worsen, hypoxia and may lead to cellular death in the injured brain tissue. Thus, prevention of early epileptic seizures may improve neurological outcome. However, the efficacy of a systematic prophylactic antiepileptic treatment on clinical and subclinical epileptic seizures has not been evaluated in the setting of intracerebral haemorrhage. The current European guidelines recommend the use of antiepileptic drugs only when epileptic seizures occur. Primary objective: PEACH is a randomized controlled trial aiming at evaluating the impact of systematic prophylactic antiepileptic treatment with levetiracetam versus placebo in acute supratentorial spontaneous intracerebral haemorrhage. The primary endpoint is the occurrence of at least one clinical or electrical epileptic seizure recorded on continuous 48h holter EEG. Secondary Objectives:This study also aims to assess: Ä The efficacy of prophylactic treatment with levetiracetam on the number of EEG seizures, on the total duration of epileptic seizures continuously recorded on EEG, on the occurrence of some paroxysmal EEG patterns, on the number of clinical seizures occurred during 72 hours of diagnosis, on the occurrence of early (day-0 to day-30 ) and late (from day-30 to 12 months) clinical seizures, on the functional prognosis at 3 , 6 and 12 months evaluated by the modified Rankin scale , on the cerebral oedema and mass effect evaluated by comparing the admission brain CT scan with the control CT scan performed at 72 hours, on the neurological status as assessed by the National Institute of Health Stroke Scale at 72 hours , 1 month and 3 months and on the quality of life measured by the Stroke impact Scale at 3, 6 and 12 months. Ä The frequency of side effects related to treatment with levetiracetam (anxiety and depression assessed by the Hospital Anxiety and Depression Scale at 1 and 3 months) Sample Size: 104 patients will be recruited over 2 years.
"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy
StrokeThis clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres. Patients coming to the emergency department with bleeding in the brain not due to trauma or other known causes who can be treated within 6 hours of onset will undergo CT angiography using standard CT scanners ("CAT scan"). Those with a "spot sign", a type of marker on the CT scan that shows the brain is still bleeding, will be randomly assigned to a single injection of "factor 7"(a blood clotting drug used in hemophilia) or placebo (inactive saline); patients without a spot sign will not be treated. The researchers will look at how much bleeding happens after the treatments are administered, as well as clinical outcomes such as death and disability. The researchers think that factor 7 will cause the bleeding to stop faster and possibly decrease death and disability.