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The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA, Cathflo® Activase® Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cathflo Activase, Normal saline
Johns Hopkins University
Johns Hopkins University
Published on BioPortfolio: 2014-08-27T03:26:32-0400
The specific objective of this trial is to determine the lowest dose possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular ...
This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dis...
Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the United States. In the emergent setting, patients with obstructive hydrocephalus are routi...
The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.
The 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 procedure ...
We aimed to compare the level of significance of risk factors related Intraventricular hemorrhage (IVH) between preterm infants born after IVF and non-IVF conceptions.
Intracerebral hemorrhage (ICH) is a stroke subtype associated with significant morbidity and mortality. The purpose of this review is to provide an update on important research on ICH over the past th...
Primary intraventricular hemorrhage (PIVH) is rare in the aging population and remains a challenge for cerebrovascular surgeons. In the present study, the authors reviewed the patient characteristics,...
To develop and validate a new risk score for intraventricular hemorrhage (IVH) in preterm neonates based on continuous glucose monitoring (CGM).
Ruptured aneurysms causing intraventricular hemorrhage (IVH) are associated with high morbidity. The presence of blood that completely fills the fourth ventricle (cast fourth ventricle, CFV) is though...
Bleeding within the CEREBRAL VENTRICLES. It is associated with intraventricular trauma, aneurysm, vascular malformations, hypertension and in VERY LOW BIRTH WEIGHT infants.
A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.
A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.
A nutritional condition produced by a deficiency of VITAMIN E in the diet, characterized by posterior column and spinocerebellar tract abnormalities, areflexia, ophthalmoplegia, and disturbances of gait, proprioception, and vibration. In premature infants vitamin E deficiency is associated with hemolytic anemia, thrombocytosis, edema, intraventricular hemorrhage, and increasing risk of retrolental fibroplasia and bronchopulmonary dysplasia. An apparent inborn error of vitamin E metabolism, named familial isolated vitamin E deficiency, has recently been identified. (Cecil Textbook of Medicine, 19th ed, p1181)
Hemorrhage within the orbital cavity, posterior to the eyeball.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...