Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage (IVH)
This study is currently recruiting participants.
Verified January 2010 by Albany Medical College
Sponsor:
Albany Medical College
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01064011
First received: February 5, 2010
Last updated: June 24, 2011
Last verified: January 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 5, 2010 | ||||||||
| Last Updated Date | June 24, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01064011 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage | ||||||||
| Official Title ICMJE | A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation | ||||||||
| Brief Summary | 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 routinely treated with placement of an external ventricular drain. This study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Intraventricular Hemorrhage | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 34 | ||||||||
| Estimated Completion Date | January 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01064011 | ||||||||
| Other Study ID Numbers ICMJE | 01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Yu-hung Kuo, MD, Albany Medical College | ||||||||
| Study Sponsor ICMJE | Albany Medical College | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Albany Medical College | ||||||||
| Verification Date | January 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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