Effect of Memantine on the Outcome of Patients with Intracranial hemorrhage

Phase 2

• Conditions: Intracerebral haemorrhage.; Intracerebral haemorrhage in hemisphere, unspecified

• Registration Number: IRCT201305128490N2
• Lead Sponsor: Deputy of research, Guilan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.