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Intracranial Hemorrhages clinical trials

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NCT ID: NCT03209258 Completed - Stroke Clinical Trials

The Third, Intensive Care Bundle With Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial

INTERACT3
Start date: December 12, 2017
Phase: N/A
Study type: Interventional

Continued 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.

NCT ID: NCT03153150 Completed - Atrial Fibrillation Clinical Trials

Start or STop Anticoagulants Randomised Trial (SoSTART)

SoSTART
Start date: March 28, 2018
Phase: Phase 3
Study type: Interventional

Primary research question: For adults surviving spontaneous (non-traumatic) symptomatic intracranial haemorrhage with persistent/paroxysmal atrial fibrillation/flutter (AF), does starting full treatment dose oral anticoagulation (OAC) result in a beneficial net reduction of all serious vascular events compared with not starting OAC? Trial design: Investigator-led, multicentre, randomised, open, assessor-masked, parallel group, clinical trial of investigational medicinal product (CTIMP) prescribing strategies. Investigators plan for a pilot phase, followed by a safety phase.

NCT ID: NCT03115450 Completed - Stroke Clinical Trials

Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

CUSPICP
Start date: April 1, 2018
Phase:
Study type: Observational

The purpose of this investigator-initiated study is to compare the use of pupilometer and ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if there is a value that could be used to indicate elevated ICP with either modality as these numbers are inconsistent throughout the literature. Patients that have either an external ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt are placed the patient will undergo pupilometer examination (standard of care) followed by ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be recorded. The same patient may have multiple readings performed if there is a change in ICP either spontaneously or due to intervention.

NCT ID: NCT03111654 Completed - Atrial Fibrillation Clinical Trials

A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle

RIVAFAG
Start date: July 14, 2016
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Preventing the thromboembolic risk associated with FMD is therefore a public health issue. The reference treatment is oral anticoagulation but this treatment is contraindicated in patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle is a recent technique which makes it possible to exclude this appendix from the left atrium where the majority of thrombi are formed in the framework of the AF. Comparative studies have shown the effectiveness of this technique, appearing to be similar to that of anticoagulation. However, in view of the per-procedural risk, the indication of closure was retained by the health authorities only in the event of a contraindication to oral anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients with a history of intracranial hemorrhage are therefore candidates for this technique, but there are few studies where these patients were included. The risk-benefit must be demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming functional and cognitive.

NCT ID: NCT03038087 Completed - Stroke, Acute Clinical Trials

A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage

Start date: February 23, 2017
Phase: N/A
Study type: Interventional

The purpose of this research study is to find out whether a device for monitoring bleeding in patients with acute hemorrhagic stroke will show similar findings as CT scans performed to evaluate the stroke.

NCT ID: NCT02996851 Completed - Clinical trials for Embolism and Thrombosis

Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs

Start date: January 2007
Phase: N/A
Study type: Observational

Oral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have particularly devastating consequences with high morbidity, disability and mortality rates. The efficacy and safety profiles of OAMs are generally assessed in randomized controlled trials (RCT), but included patients are often highly selected and may not be representative of users in everyday clinical practice in terms of follow-up routines, age, gender, drug compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are registered and reported in RCTs. Drifts in indications and treatment criteria may also be seen in everyday practice and drug discontinuation due to precautionary concerns including compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead to other and potentially higher traumatic ICH rates in general clinical use than reported in RCTs. The incidence rates of traumatic ICH in patients on OAMs in the general population remain unknown. In this nationwide registry based pharmacoepidemiological study we will investigate the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through 2014.

NCT ID: NCT02881957 Completed - Stroke Clinical Trials

Hypovitaminosis D in Neurocritical Patients

Start date: October 10, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Vitamin D has been shown to impact prognosis in a variety of retrospective and randomized clinical trials within an intensive care unit (ICU) environment. Despite these findings, there have been no studies examining the impact of hypovitaminosis D in specialized neurocritical care units (NCCU). Given the often significant differences in the management of patients in NCCU and more generalized intensive care units there is a need for further inquiries into the impact of low vitamin D levels in this specific environment. This study proposes a randomized, double-blinded, placebo-controlled, single center evaluation of vitamin D supplementation in the emergent NCCU patient population. The primary outcome will involve length-of-stay for emergent neurocritical care patients. Various secondary outcomes, including in-hospital mortality, ICU length-of-stay, Glasgow Outcome Score on discharge, complications and quality-of-life metrics. Patients will be followed for 6 months post-discharge.

NCT ID: NCT02811614 Completed - Clinical trials for Intracranial Hemorrhage, Hypertensive

Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage

MISICH
Start date: July 1, 2016
Phase: N/A
Study type: Interventional

The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. Two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. However, prospective and controlled studies are still lacking. This is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.

NCT ID: NCT02809651 Completed - Ischemic Stroke Clinical Trials

Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner

Start date: August 2016
Phase: N/A
Study type: Interventional

The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.

NCT ID: NCT02777424 Completed - Clinical trials for Intracranial Hemorrhages

CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

CLOT-CRANE
Start date: January 21, 2016
Phase: Phase 4
Study type: Interventional

This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).