Text Size

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

This study is currently recruiting participants.
Verified April 2013 by Johns Hopkins University
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech
Information provided by (Responsible Party):
Daniel Hanley, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00784134
First received: October 31, 2008
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  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 3

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:

Drug Information available for: Alteplase
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 12 doses
Other Names:
  • Cathflo Activase
  • rt-PA
Placebo Comparator: Saline Placebo
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 12 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

  Show 71 Study Locations
Sponsors and Collaborators
Daniel Hanley
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 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: April 1, 2013
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 May 23, 2013