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| Name | Class |
|---|---|
| Ever Neuro Pharma GmbH | INDUSTRY |
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Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.
Participants: patients with prolonged disorders of consciousness due to severe traumatic brain injury
Intervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously or 100 ml normal saline, days 4-17, once/day, IV
Comparison: cerebrolysin group versus control group
Outcome: Coma Recovery Scale-revised, FDG-PET signal
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebrolysin | Experimental | 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously |
|
| Control | Placebo Comparator | 100 ml normal saline, days 4-17, once/day, IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrolysin | Drug | 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coma Recovery Scale - revised | Assessing the degree of disorders of consciousness | 2 days after randomization |
| Coma Recovery Scale - revised | Assessing the degree of disorders of consciousness | 17 days after randomization |
| Positron Emitting Tomography | Assessing the degree of brain neural network activity | 2 days after randomization |
| Positron Emitting Tomography | Assessing the degree of brain neural network activity | 17 days after randomization |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jongmin Lee, M.D., Ph.D. | Contact | +821063558073 | jongminleemd@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center Research Coordinating Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32057086 | Background | Lee S, Lee HH, Lee Y, Lee J. Additive effect of cerebrolysin and amantadine on disorders of consciousness secondary to acquired brain injury: A retrospective case-control study. J Rehabil Med. 2020 Feb 27;52(2):jrm00025. doi: 10.2340/16501977-2654. | |
| 22375973 | Background | Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A, Eifert B, Long D, Katz DI, Cho S, Yablon SA, Luther M, Hammond FM, Nordenbo A, Novak P, Mercer W, Maurer-Karattup P, Sherer M. Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med. 2012 Mar 1;366(9):819-26. doi: 10.1056/NEJMoa1102609. |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C006952 | cerebrolysin |
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| Control | Drug | 100 ml normal saline, days 4-17, once/day, IV |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |