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7 active trials for Intracranial Hemorrhage

INVEST-REGISTRY: Minimally Invasive Endoscopic Surgical Treatment With Apollo/Artemis in Patients With Brain Hemorrhage

Objective: The primary objective of this multicenter prospective registry is to provide additional safety, technical outcomes and clinical outcomes data for minimally invasive endoscopic surgery (MIES) with Apollo or Artemis for the evacuation of supratentorial brain hemorrhage in adult patients who do not qualify for the concurrent INVEST Feasibility randomized controlled trial at active INVEST centers.

Start: October 2016

INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain Hemorrhage

The primary objective of this multicenter single arm feasibility study is to provide an assessment of enrollment and follow up feasibility for this patient population being treated with the Apollo Minimally Invasive Surgical Treatment (MIES). Patients who do not qualify for the INVEST Feasibility Study will be referred to the INVEST Registry study.

Start: June 2017

Application of Magnesium-rich Artificial Cerebrospinal Fluid in Nonaneurysmal Subarachnoid Hemorrhage

Intracerebral hemorrhage (ICH) is one of the common fatal types of cerebral apoplexy with high mortality and disability rates. Hematoma volume and complications of intracerebral hemorrhage are major predictors of early death and poor prognosis. The hematoma and its metabolites are key therapeutic targets. At present, in order to improve the prognosis of patients, cerebrospinal fluid(CSF) replacement with normal saline(NS) is commonly used in clinical practice to clear the bloody components, which shows a good clinical effect. However, due to the large difference between NS and CSF composition, it is easy to cause secondary injury of brain tissue. Therefore, the replacement of artificial CSF with similar CSF composition will be more effective in reducing the incidence of complications and improve the prognosis of neurological function. The Magnesium-rich Artificial Cerebrospinal Fluid(MACSF) designed and developed in the early stage of this project which has similar physical and chemical properties to physiological CSF, such as ion species, concentration, potential of hydrogen (pH) value and osmotic pressure. Animal experiments has confirmed its safety and effectiveness. In this study, patients with basal ganglia intracerebral hemorrhage ruptured into the ventricle or nonaneurysmal subarachnoid hemorrhage were stratified randomly divided into MACSF group and NS group. MACSF and NS were used as replacement fluid for lumbar puncture CSF replacement, respectively. By observing and compare two groups of patients of the Modified Rankin Scale (mRS) in the day of 14, 30, 60, 90 days after onset; hematoma absorption rate, hemorrhagic CSF removal rate; changes of cerebral autoregulation? incidence of complications, such as acute obstructive hydrocephalus (AOH) and cerebral vasospasm (CVS); the changes of scores and scales about imaging; assessment of neurological function recovery, such as the National Institutes of Health Stroke Scale (NIHSS) and the Glasgow Coma Score (GCS) during hospitalization, headache duration and the Visual Analogue Scale (VAS), vomiting duration, duration of meningeal irritant, ICU hospitalization duration, total hospitalization duration; change of CSF and peripheral blood biochemical indicators. Objective to evaluate MACSF replacement therapy in patients with basal ganglia cerebral hemorrhage broken into ventricles and nonaneurysmal subarachnoid hemorrhage of the influence of absorption rate and prognosis.

Start: April 2021

MIECH: The Minimally Invasive Endoscopic Surgery With the Axonpen System for Spontaneous Intracerebral Hemorrhage

The primary objective of this trial is to provide preliminary safety data of the minimally invasive endoscopic surgery using the Axonpen™ system for spontaneous intracerebral hemorrhage (ICH). The effectiveness of the Axonpen™ system in early hematoma removal and the surgical impact on subject's functional recovery will also be evaluated. The Axonpen™ system, consisting of a neuroendoscope (Axonpen) and a monitor (Axonmonitor), is cleared by FDA and indicated for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum.

Start: August 2020

Atrial Fibrillation as a Cause of Stroke and Intracranial Hemorrhage Study (The FibStroke Study)

The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage. Primary Outcome Measures: - Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to diagnosis and anticoagulation treatment of AF during the study period; comparison of complications between those with and without anticoagulation treatment according to CHADSVASc score. Secondary Outcome Measures: The effect of anticoagulation pauses and INR level on stroke and bleeding risk; strokes within 30 days after anticoagulation pause and the prevalence of stroke and intracranila bleeding in relation to INR level < 2, 2-3 and >3. Trauma as a risk factor for intracranial bleeding: percentage and risk factors for intracranial bleeding with or without trauma. Type of preceding trauma and type of intracranial bleeding. The time relation between diagnosis of AF and type of intracranial complications: Kaplan Meier analysis of thrombotic (Stroke/TIA) and intracranial bleeding complications after 1st diagnosis of AF in patients with and without anticoagulation The risk of stroke and intracranial bleeding in relation to CHADSVASc score, HAS-BLED score and anticoagulation/antithrombotic treatment Prognosis of stroke and intracranial bleeding: 30-day mortality after stroke and intracerebral bleeding in patients with and without anticoagulation Factors related to underuse of anticoagulation treatment. Data on reasons for not starting or stopping aticoagulation in those with indication of oral anticoagulation Operations and procedure as risk factor for stroke: Frequency and type of operations performed < 30 days before stroke. Data on length of perioperative pause in anticoagulation and use of bridging therapy and timiing of stroke are collected. Cardioversions as a risk factor for stroke: Frequency of stroke and TIA < 30 days after cardioversion in relation to use of anticoagulation and CHADSVASc score The risk of stroke and intracranial bleeding in relation to type of AF (permanent, persistent, paroxysmal) and concomitant carotid disease Estimated Enrollment: 6000 patients.

Start: October 2013

Registration of Idarucizumab for Patients With IntraCranial Hemorrhage

This multicenter, prospective, observational, non-interventional study investigates patients with intracranial hemorrhage under effective anticoagulation with dabigatran or vitamin-K antagonist (VKA). Routine data will be collected during hospitalization. Patients aged 18 years or older under effective therapy with dabigatran and symptomatic intracranial bleeding confirmed by cerebral imaging and treated with idarucizumab will be compared to patients under effective treatment with VKA at the time of onset of the intracranial bleeding. Ninety-five dabigatran patients who provided written informed consent for data transmission will be included. As control group retrospective and anonymized data of 285 VKA patients patients under VKA treatment and admitted to RIC-ICH study centers will be used. For each patient receiving idarucizumab, three patients with intracranial hemorrhage under effective treatment with VKA, will be included (retrospective) in the study. In addition, data of VKA patients will be transferred from the RASUNOA-PRIME and the "Erlanger Hirnblutungs-Register".

Start: September 2019

Observational Study in Preterm Infants With Intracranial Hemorrhage

Intracranial Hemorrhage (ICH) is an important morbidity affecting premature infants and can have considerable effects on neurodevelopmental outcome. The investigators showed that preterm infants with severe ICH have decreased cerebral oxygenation several weeks after the hemorrhage. The mechanisms involved in this state of decreased cerebral oxygenation in preterm infants and the effects on cerebral function are unknown. This longitudinal observation study will evaluate physiologic parameters to determine trends in cerebral oxygenation and function in preterm infants with ICH in comparison to infants without ICH.

Start: June 2012