Clinical Trial on Treatment of Intraventricular Hemorrhage
NCT ID: NCT00650858
Last Updated: 2017-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2004-02-29
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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0.3 mg rt-PA
In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage.
tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
1.0 mg rt-PA
In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage.
tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
1.0 mg Rt-PA q8h
In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage.
tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
Interventions
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tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. IVC placed as standard of care using less than or equal to 2 complete passes.
3. Spontaneous ICH less than or equal to 30 cc.
4. Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
6. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).
7. SBP \< 200 mmHg sustained for 6 hours.
8. Historical Rankin of 0 or 1.
Exclusion Criteria
2. Clotting disorders.
3. Patients with platelet count \< 100,000, INR \> 1.7, PT \> 15s, or an elevated APTT.
4. Pregnancy (positive pregnancy test).
5. Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
6. SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).
7. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).
8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.
10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.
11. Prior enrollment in the study.
12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
13. Participation in another simultaneous medical investigation or trial.
18 Years
75 Years
ALL
No
Sponsors
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FDA Office of Orphan Products Development
FED
Genentech, Inc.
INDUSTRY
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Daniel F Hanley, MD
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
CR Drew Medical Center
Los Angeles, California, United States
Standford Medical Center
Palo Alto, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Loyola University Medical Center
Maywood, Illinois, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
University of Maryland Medical Systems
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Louis University
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas HSC, San Antonio
San Antonio, Texas, United States
University of Virginia, Charlottesville
Charlottesville, Virginia, United States
INOVA Fairfax Medical Center
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Foothills Medical Centre
Calgary, Alberta, Canada
University of Heidelberg
Heidelberg, , Germany
Newcastle General Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Kornbluth J, Nekoovaght-Tak S, Ullman N, Carhuapoma JR, Hanley DF, Ziai W. Early Quantification of Hematoma Hounsfield Units on Noncontrast CT in Acute Intraventricular Hemorrhage Predicts Ventricular Clearance after Intraventricular Thrombolysis. AJNR Am J Neuroradiol. 2015 Sep;36(9):1609-15. doi: 10.3174/ajnr.A4393. Epub 2015 Jul 30.
Ziai W, Moullaali T, Nekoovaght-Tak S, Ullman N, Brooks JS, Morgan TC, Hanley DF. No exacerbation of perihematomal edema with intraventricular tissue plasminogen activator in patients with spontaneous intraventricular hemorrhage. Neurocrit Care. 2013 Jun;18(3):354-61. doi: 10.1007/s12028-013-9826-1.
Morgan TC, Dawson J, Spengler D, Lees KR, Aldrich C, Mishra NK, Lane K, Quinn TJ, Diener-West M, Weir CJ, Higgins P, Rafferty M, Kinsley K, Ziai W, Awad I, Walters MR, Hanley D; CLEAR and VISTA Investigators. The Modified Graeb Score: an enhanced tool for intraventricular hemorrhage measurement and prediction of functional outcome. Stroke. 2013 Mar;44(3):635-41. doi: 10.1161/STROKEAHA.112.670653. Epub 2013 Jan 31.
Webb AJ, Ullman NL, Mann S, Muschelli J, Awad IA, Hanley DF. Resolution of intraventricular hemorrhage varies by ventricular region and dose of intraventricular thrombolytic: the Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR IVH) program. Stroke. 2012 Jun;43(6):1666-8. doi: 10.1161/STROKEAHA.112.650523. Epub 2012 Apr 3.
Ziai WC, Muschelli J, Thompson CB, Keyl PM, Lane K, Shao S, Hanley DF. Factors affecting clot lysis rates in patients with spontaneous intraventricular hemorrhage. Stroke. 2012 May;43(5):1234-9. doi: 10.1161/STROKEAHA.111.641050. Epub 2012 Mar 1.
Herrick DB, Ziai WC, Thompson CB, Lane K, McBee NA, Hanley DF. Systemic hematologic status following intraventricular recombinant tissue-type plasminogen activator for intraventricular hemorrhage: the CLEAR IVH Study Group. Stroke. 2011 Dec;42(12):3631-3. doi: 10.1161/STROKEAHA.111.625749. Epub 2011 Sep 22.
Related Links
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CLEAR III Website
Other Identifiers
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ISRCTN47341677
Identifier Type: REGISTRY
Identifier Source: secondary_id
IVH05
Identifier Type: -
Identifier Source: org_study_id