Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage (IVH)
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|ClinicalTrials.gov Identifier: NCT01064011|
Recruitment Status : Unknown
Verified January 2010 by Albany Medical College.
Recruitment status was: Recruiting
First Posted : February 8, 2010
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Intraventricular Hemorrhage||Procedure: Rt-PA thrombolysis Procedure: endoscopic hematoma evacuation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
|External Ventricular drainage, Intraventricular Thrombolysis||
Procedure: Rt-PA thrombolysis
patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.
|External Ventricular Drainage and Endoscopic Evacuation||
Procedure: endoscopic hematoma evacuation
In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064011
|Contact: Yu-Hung Kuo, MD||518 firstname.lastname@example.org|
|Contact: Tyler Kenning, MD||518 email@example.com|
|United States, New York|
|Albany Medical Center||Recruiting|
|Albany, New York, United States, 12208|
|Contact: Yu-Hung Kuo, MD 518-262-5088 firstname.lastname@example.org|
|Contact: Tyler Kenning, MD 518 262-5088 email@example.com|