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IRCT201305128490N2 IRCT 2013-05-19 Deputy of research, Guilan University of Medical Sciences Effect of Memantine on the Outcome of Patients with Intracranial hemorrhage Effect of Memantine versus Placebo on the Outcome and Functional Recovery of Patients with Intracranial hemorrhage: a double-blind randomized placebo-controlled pilot trial 2013-06-22 anticipated 60 Complete https://irct.ir/trial/8955 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Intracerebral haemorrhage. Intervention 1: Memantine , 10 mg oral pill daily for the first month and 20mg forthe next two months. Intervention 2: Placebo, 10 mg oral pill daily for the first month and 20mg for the next 2 months.
public Dr Mohadeseh Hajinoori
Poursina Hospital
Rasht Iran (Islamic Republic of) 4193893345 +98 911 193 0396 dr.hajinoori@gmail.com Guilan University of Medical Science scientific Seyed Mohammad Seyed Saadat
Student Research Comittee, Deputy of research, Across Sepah bank, West shahid beheshti bolvard,Gas square
Rasht Iran (Islamic Republic of) 4193893345 +98 13 1322 8905 sm_seyedsaadat@gums.ac.ir Research comittee, Guilan university of Medical Science Iran (Islamic Republic of) The inclusion criteria: 1. Patients with the diagnosis of first ever, spontaneous, non-traumatic supratentorial ICH confirmed by a clinical examination and radiological findings 2. Admission NIHSS <20 3. Patients whom diagnosis is made within less than 6 hours after onset of symptoms 4. Patients with a length of hospital stay of at least 7 days 5. Age <80 6. Admission GCS >5 7. Admission hematoma volume <30 cc Patients who will not include: 1.Those with previous or concomitant ischemic stroke 2.Those with other systemic disease including liver or kidney failure 3. Those who have pace maker, or suffer from severe neuropathy, systemic vascular disease or major affective disorders. 4. Those with a positive history of severe disability due to neurological or non-neurological causes 5.Those with a previous history of ICH, myocardial infarction or ischemic stroke 6. Those who abuse alcohol 7. Those with confirmed diagnosis of cognitive disorders based on DSM-IV criteria for dementia or IQCODE questionnaire 8. Those with ICH secondary to brain trauma or rupture of brain aneurysm 9. Those with a history of using anticoagulant drugs, antiplatelet drugs and NSAIDs. 10. Pregnant patients 11. Those with concomitant Intraventricular hemorrhage (IVH) 12.Deep coma Exclusion criteria: 1. Refusal to continue with the study 2. The occurrence of serious adverse drug affects at any time during the study. 3. Alcohol abuse during the study period no limit no limit Both I61.2 Intracerebral haemorrhage in hemisphere, unspecified Treatment - Drugs Placebo Memantine , 10 mg oral pill daily for the first month and 20mg forthe next two months Placebo, 10 mg oral pill daily for the first month and 20mg for the next 2 months Mortality. Timepoint: During the three-month follow-up period. Method of measurement: Mortality rate. Functional recovery. Timepoint: On admission, 7th day, and on discharge. Method of measurement: National Institute of Health Stroke Scale(NIHSS). Motor recovery. Timepoint: On admission, 7th day, on discharge, and 3 month later. Method of measurement: Fugl-Meyer (FM). Disability. Timepoint: On admission, 7th day, on discharge, and 3 month later. Method of measurement: modified Rankin Scale(mRS). Performance in basic Activities of Daily Living. Timepoint: On admission, 7th day, on discharge, and 3 month later. Method of measurement: Barthel index (BI). Level of consciousness. Timepoint: On admission, 7th day, and on discharge. Method of measurement: Glosgow coma scale (GCS). Changes in the size of hematoma. Timepoint: On admission, 72 hours later, and 7th day. Method of measurement: Based on the findings of CT scan. Changes in the size of perihematomal edema. Timepoint: On admission, 72 hours later, and 7th day. Method of measurement: Based on the findings of CT scan. Deputy of research, Guilan University of Medical Sciences Approved 2013-02-09 Ethics committee of Guilan University of Medical Sciences Student Research Comittee, Deputy of research, Across Sepah bank, West shahid beheshti bolvard,Gas square Rasht Iran (Islamic Republic of)