Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
Intracranial HemorrhagesThe multicenter, prospective, observational, non-interventional study conducted in German Stroke Units is investigating patients with intracranial hemorrhage (ICH) under effective anticoagulation with rivaroxaban or apixaban. The aim of the study is to analyze under routine conditions wether the volume increase of ICH under treatment with rivaroxaban and apixaban can be reduced with the antidote andexanet alfa. Thus, data of patients under effective treatment with rivaroxaban or apixaban and treated with andexanet alfa at baseline will be assessed at the time of onset of ICH, during the hospital stay and during a follow-up by telephone at 30 and 90 days after hospital discharge. The main objective is defined as the change in size or volume of the hematoma by computed tomography (CT) or magnetic resonance imaging (MRI) in patients with ICH under effective treatment with rivaroxaban and apixaban, who are treated with andexanet alfa. Further objectives comprise evaluations concerning the functional status according to modified Rankin Scale (mRS), changes in the National Institutes of Health Stroke Scale (NIHSS), and occurrences of ICH or new intraventricular bleeding as well as mortality rates.
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Sufentanil
HealthyThis study will examine how sufentanil (a commonly used pain medication) will alter responses to simulated blood loss in humans. To simulate blood loss in the research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.
Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
Subarachnoid HemorrhageAneurysmal1 moreMulticentric registry study in order to define outcome, predictors, treatment effects and their modifiers in poor grade aneurysmal subarachnoid haemorrhage patients. The search for outcome predictors is going to be subdivided into three main research areas: outcome predictors in the emergency department (so called "early brain injury phase"). outcome predictors in the neurocritical care unit (so called "delayed brain injury phase"). Treatment strategies. Two other areas of research are identified: delayed cerebral ischemia (incidence, treatment, predictors, impact on outcome) and long term follow-up (recent evidences suggest that there may be a non-negligible proportion of poor grade subarachnoid hemorrhage patients who may benefit from substantial improvement at long-term (after 6-12 months of follow-up).
Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study
Traumatic Brain InjurySubarachnoid Hemorrhage4 moreThe NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial
Cerebral Nitrosative/Oxidative Stress in Aneurysmal Subarachnoid Haemorrhage
Subarachnoid HemorrhageAneurysmalAneurysmal subarachnoid haemorrhage (SAH) carries a high morbidity and mortality, which is in part due to the development of secondary brain injury. The mechanisms behind this remain incompletely understood, but oxidative/nitrosative stress and disturbances in vasoregulatory mechanisms are believed to be involved. The present study aims to characterise the transcerebral exchange of oxidative/nitrosative stress markers and nitric oxide metabolites during the early phase after SAH compared to healthy volunteers, including the influence of induced changes in arteriel oxygen tension.
Minocycline Accelerates Intracerebral Hemorrhage Absorption
Intracerebral HemorrhageMinocycline has been found to reduce cerebral edema secondary to cerebral hemorrhage, promote hematoma absorption, and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment, but no significant hematoma absorption effect was seen with short duration of drug use. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption.
Cerebrospinal Fluid Hemoglobin to Monitor for Aneurysmal Subarachnoid Hemorrhage Related Secondary...
Subarachnoid HemorrhageAneurysmal3 moreThe primary objective of this study is to evaluate the association between hemoglobin levels in the cerebrospinal fluid (CSF-Hb) and the occurrence of secondary brain injury in patients after aneurysmal subarachnoid hemorrhage (SAH-SBI) during the first 14 days after bleeding.
The Akershus Study of Ischemic Stroke and Thrombolysis -1
StrokeAcute4 moreThis observational study comprises consecutively patients with cerebrovascular diseases admitted to the Stroke Unit at Akershus University Hospital in Norway. Akershus University Hospital is the largest emergency care hospital in Norway and has a catchment area covering a population of 550.000, which is approximately 10 % of the Norwegian population and reasonably representative according to data from Statistics Norway. The hospital is public and serving both as a primary hospital and a university hospital. Due to the Norwegian, national, all-covering health-insurance, all patients enter the hospital and are considered for further in-patient care on the same conditions. The hospital has a stroke unit classified as a comprehensive stroke center according to European Stroke Organisation standards. Acute stroke management follows national and international guidelines. A stroke fast track aiming to reduce in-hospital delay was established in 2012 and thrombectomy was established in 2019. Overall, the ASIST-1 study will investigate management, outcome and prognosis of stroke and stroke care pathways using several approaches combining existing clinical data from a representative population with different Norwegian health registries. Parts of the study are retrospective with prospective follow-up by health registries and parts of the study are prospective.
EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
HemorrhageBleeding HemorrhageThis is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from "real-world" use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval. Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.
VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely...
Intraventricular HemorrhageThe purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to standard care of providing ventilatory assistance after cord clamping.