Beta-hCG + Erythropoietin in Acute Stroke (BETAS)
|ClinicalTrials.gov Identifier: NCT00362414|
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : August 29, 2016
Last Update Posted : August 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Acute Stroke||Drug: Dual Growth Factor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Beta-hCG + Erythropoietin in Acute Stroke|
|Study Start Date :||August 2006|
|Primary Completion Date :||March 2008|
|Study Completion Date :||March 2008|
Experimental: Dual Growth Factor
All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.
Drug: Dual Growth Factor
10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation
30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation
- Safety [ Time Frame: 3 mo ]Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.
- Morbidity [ Time Frame: 3 mo ]attributable to experimental intervention
- Mortality [ Time Frame: 3 mo ]attributable to experimental intervention
- Action Research Arm Test [ Time Frame: 3 mo ]The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. Total scores range from 0-57 points, a higher score being better with 57 being considered "normal".
- Fugl-Meyer Arm Scale [ Time Frame: 3 mo ]Fugl-Meyer arm scale is a measurement scale of the upper body with three sections being Proximal, Wrist/Hand, and Coordination/Speed. The scores can range from 0-66 with a higher score being better. A score of 66 is considered "normal" with no impairments.
- Fugl-Meyer Leg Scale [ Time Frame: 3 mo. ]Measure of leg motor impairment with three subsections which are Proximal, Hip/Knee, and Speed/Coordination. The scale ranges from 0-34 with a higher score being better. A score of 34 is considered "normal".
- Boston Naming Test [ Time Frame: 3 mo ]Measure of aphasia or other language disturbance caused by stroke or other dementing disorders. It consists of 60 line drawings graded in difficulty in which patients are to name each picture.
- Line Cancellation Test [ Time Frame: 3 mo ]Measure of spatial neglect where patients must cross out lines placed in a random orientation. Missed lines may indicate areas of spatial neglect.
- NIH Stroke Scale [ Time Frame: 3 mo ]Measure of global impairment post stroke. It includes 11 items to examine levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scoring scale is between 0-42 where a higher score is indicative of a more severe stroke.
- Geriatric Depression Scale Short Form [ Time Frame: 3 mo ]Measure of depression done as a self-report. It is a series of 15 questions designed to be a screen for depression. The scores range from 0-15 with a higher score being more indicative of depression.
- Barthel Index [ Time Frame: 3 mo ]Measure of disability in terms of performance of activities of daily living (ADL). The scores range from 0-100 with a higher score being associated with a higher level of independence.
- Infarct Volume Using Anatomical MRI [ Time Frame: 3 mo ]Measurement of infarct volume and percent change from baseline to Day 90.
- Trail Making A Test [ Time Frame: 3 mo ]Measure of memory and executive function where one is asked to connect dots consecutively based on the number of the dot. Test taker is allowed 2 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.
- Trail Making B Test [ Time Frame: 3 mo. ]Measure of memory and executive function where one is asked to connect dots with letters and numbers alternating between number and letter and connecting dots consecutively. Test taker is allowed 4 minutes to connect the dots with a maximum score of 25 for all dots connected correctly.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362414
|United States, California|
|University of California, Irvine Medical Center|
|Orange, California, United States, 92868-4280|
|Principal Investigator:||Steven C. Cramer, MD, MMSc||University of California, Irvine|