Advertisement

Topics

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

2014-08-27 03:26:32 | BioPortfolio

Summary

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).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Intraventricular Hemorrhage

Intervention

Cathflo Activase, Normal saline

Location

Johns Hopkins University
Baltimore
Maryland
United States
21230

Status

Recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:32-0400

Clinical Trials [1272 Associated Clinical Trials listed on BioPortfolio]

Phase II Clinical Trial on Treatment of Intraventricular Hemorrhage

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 ...

Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

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...

Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

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...

Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial

The purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

MIS+rtPA for ICH Evacuation

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 ...

PubMed Articles [5759 Associated PubMed Articles listed on BioPortfolio]

Comparison of Risk Factors Related to Intraventricular Hemorrhage between Preterm Infants Born After Normal and in Vitro Fertilization Conceptions.

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.

Recent advances in spontaneous intracerebral hemorrhage.

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...

Clinical features and prognosis of primary intraventricular hemorrhage in the elderly: a single center experience.

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,...

Continuous Glucose Monitoring Linked to an Artificial Intelligence Risk Index: Early Footprints of Intraventricular Hemorrhage in Preterm Neonates.

To develop and validate a new risk score for intraventricular hemorrhage (IVH) in preterm neonates based on continuous glucose monitoring (CGM).

The Prognostic Significance of a Cast Fourth Ventricle in Ruptured Aneurysm Patients With Intraventricular Hemorrhage in the Barrow Ruptured Aneurysm Trial (BRAT).

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...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
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...

Alzheimer's Disease
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...


Searches Linking to this Trial