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Intracerebral Hemorrhage clinical trials

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NCT ID: NCT02920645 Enrolling by invitation - Clinical trials for Intracerebral Hemorrhage

Multicenter Validation of the AVICH Score

AVICH
Start date: September 2016
Phase: N/A
Study type: Observational

The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH. Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared. Multicentre validation study Key inclusion criteria: - All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage - Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria. Key exclusion criteria: - incomplete data set - AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH

NCT ID: NCT02880878 Completed - Clinical trials for Intracerebral Hemorrhage

ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)

ENRICH
Start date: December 2016
Phase: N/A
Study type: Interventional

This 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.

NCT ID: NCT02866838 Completed - Clinical trials for Intracerebral Hemorrhage

Treatment of Intracerebral Hemorrhage in Patients on Non-vitamin K Antagonist

TICH-NOAC
Start date: December 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Novel, 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.

NCT ID: NCT02830152 Active, not recruiting - Stroke Clinical Trials

Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage

Start date: May 3, 2017
Phase: N/A
Study type: Interventional

Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.

NCT ID: NCT02687191 Terminated - Clinical trials for Intracerebral Hemorrhage

Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage

Start date: November 2016
Phase: Phase 1
Study type: Interventional

This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model. Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91. Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8).

NCT ID: NCT02639819 Withdrawn - Clinical trials for Intracerebral Hemorrhage

Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

MANICHAN-PILOT
Start date: June 2016
Phase: Phase 1
Study type: Interventional

This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in ICH patients. Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within 3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over 1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic 30-90 days post discharge for functional status.

NCT ID: NCT02625948 Recruiting - Stroke Clinical Trials

Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign

TRAIGE
Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. For individuals who are at high risk for hemorrhage growth, the study will compare the drug Tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth

NCT ID: NCT02567162 Completed - Clinical trials for Intracerebral Hemorrhage

Multinational Survey of Epidemiology, Morbidity, and Outcomes in Intracerebral Hemorrhage

MNEMONICH
Start date: November 2015
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.

NCT ID: NCT02533960 Completed - Clinical trials for Cardiovascular Diseases

Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

RASUNOA-Prime
Start date: June 2015
Phase:
Study type: Observational

The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.

NCT ID: NCT02515903 Unknown status - Surgery Clinical Trials

Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage

EndoSurofICH
Start date: May 2015
Phase: N/A
Study type: Interventional

Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed effective and safe, some investigators have attempted to use endoscopic strategies to evacuate intracerebral hematomas. Some significant advances have also been reported in endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still crucial to implement a prospective and controlled study to evaluate the efficiency and safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the investigators will exclusively select some patients with intracerebral hemorrhage in the basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery versus stereotactic aspiration on neurologic outcomes for patients with intracerebral hemorrhage.