Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III - Full Text View

Sponsor:	Johns Hopkins University
Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) Genentech
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00784134

Purpose

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).

Condition	Intervention	Phase
Intraventricular Hemorrhage	Drug: Cathflo Activase Other: Normal saline	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Modified Rankin Scale [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Amount of residual blood [ Time Frame: 72 h ] [ Designated as safety issue: No ]
Intensity of critical care management [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: rt-PA administration of rt-PA via the intraventricular catheter	Drug: Cathflo Activase 1.0 mg of Cathflo Activase will be administered via the intraventricular catheter every 8 hours for up to 9 doses Other Names: Cathflo Activase rt-PA
Placebo Comparator: 2 1 ml of normal saline administered via the intraventricular catheter	Other: Normal saline 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 9 doses Other Name: normal saline

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-80
Symptom onset less than 24 hrs prior to diagnostic CT scan
Spontaneous ICH less than or equal to 30 cc or primary IVH
IVH obstructing 3rd and/or 4th ventricles
ICH clot stability at 6 hours or more post IVC placement
IVH clot stability at 6 hours or more post IVC placement
Catheter tract bleeding stability 6 hours or more post IVC placement
EVD placed per standard medical care
SBP less than 200 mmHg sustained for 6 hours prior to drug administration
Able to randomize within 72 hours of diagnostic CT scan
Historical Rankin of 0 or 1

Exclusion Criteria:

Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
Presence of a choroid plexus vascular malformation or Moyamoya
Clotting disorders
Platelet count less than 100,000, INR greater than 1.4
Pregnancy
Infratentorial hemorrhage
SAH at clinical presentation
ICH/IVH enlargement that cannot be stabilized in the treatment time window
Ongoing internal bleeding
Superficial or surface bleeding
Prior enrollment in the study
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
No subject or legal representative to give written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784134

Contacts

Contact: Karen Lane, CMA, CCRP	(410) 614-3461	klane@jhmi.edu
Contact: Timothy Morgan	(410) 502-2949	tmorga10@jhmi.edu

Show 65 Study Locations

Sponsors and Collaborators

Johns Hopkins University

National Institute of Neurological Disorders and Stroke (NINDS)

Genentech

Investigators

Study Chair:

Daniel F. Hanley, MD

Johns Hopkins University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Daniel F. Hanley, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00784134 History of Changes
Other Study ID Numbers:	IVH06
Study First Received:	October 31, 2008
Last Updated:	June 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

intraventricular hemorrhage thrombolysis

Additional relevant MeSH terms:

Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012