Treatment of Subarachnoid Hemorrhage With Human Albumin (ALISAH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01747408|
Recruitment Status : Terminated (The study met the pre-specified criteria for stopping the trial)
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Subarachnoid Hemorrhage||Drug: Human Albumin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Subarachnoid Hemorrhage With Human Albumin|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||May 2011|
Experimental: 25% human albumin
Subjects will be entered into one of 4 increasing dosages of 25% human albumin sequentially. Once the first 20 subjects have been enrolled and the DSMB reviews data and approves moving to the next dosage tier patients will be entered into the following dosage tier.
Drug: Human Albumin
25% human albumin given in four escalating doses:
Other Name: Albumin
- Number of participatns with cardiovascular adverse events as a measure of safety and tolerability [ Time Frame: Up to 48 hours after treatment administration ]The study will investigate the number of patients experiencing moderate-to-severe acute heart failure for any given dosage tier directly related to treatment administration. Specifically, if at least 2 patients per dosage tier experience such serious event the study will be terminated.
- GOS [ Time Frame: 3 months after enrollment ]The study will measure the the Glasgow Outcome Scale to obtain preliminary estimates of treatment effects.
- mRs [ Time Frame: 3 months after study enrollment ]The study will measure the the modified Rankin Scale to obtain preliminary estimates of treatment effects.
- NIHSS [ Time Frame: 3 months after enrollment ]The study will measure the NIH Stroke Scale to obtain preliminary estimates of treatment effects.
- SIS [ Time Frame: 3 months after enrollment ]The study will measure the Stroke Impact Scale to obtain preliminary estimates of treatment effects.
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): NCT01747408
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Study Chair:||Jose I Suarez, MD||Baylor College of Medicine|