Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of a drug minocycline in improving outcomes at 3 months after rupture of an aneurysm in the head.

Detailed Description
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Prior to the drug: If you decide to take part in this study, you will have a brief interview about your medical history and any medications you are taking. You will have a medical and neurological examination, CT scan and/or an angiogram to look at the blood vessel and blood supply going to the brain, and blood samples drawn for a complete blood count, chemistry analysis and cardiac enzymes (to assess any recent damage to your heart). You will have a surgery or an image guided procedure to close your aneurysm. Additionally, during the course of the study you may be asked to have a computerized tomography (CT scan) or magnetic resonance imaging (MRI) if there is a necessity. These tests will reveal areas that might have been damaged in your brain. Drug: If the tests show that you qualify as a candidate for this study, you will be randomly assigned (like a flip of a coin) to have either the minocycline drug or a dummy drug that looks the same but does not have the drug in it. For the first 7 days, the drug will be given as an injection two times a day and after that for 14 days once a day by mouth. Rest of the care will be standard like in any aneurysm patient. We study the status of your blood vessel surrounding the brain with ultrasound daily to see if they have any narrowing. If the doctors find any narrowing, you will be treated to relive the narrowing. If you are discharged home at any point in the 21 days, you will be switch the oral drug and given the required drugs with instructions. Follow up: Before you are discharged from the hospital and at 7, 21, 30 and 90 days after the start of the drug, the following evaluations will be performed: a complete physical and neurological examinations. As part of this study, you are required to return to the hospital or to your physician at one (1), seven (7), twenty-one (21), thirty (30), ninety (90) days after stroke onset. You will have a physical exam, a complete neurological exam. Additionally, you will be asked questions about any health problems or hospitalizations you have had since you were discharged from the hospital.

Conditions
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Subarachnoid Aneurysm Hemorrhage

Intervention / Treatment
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* Drug: Minocycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 yrs of age Ruptured aneurysm Initiate treatment within 72 hours of SAH Pre Rankin ≤ 1 Exclusion Criteria: Hunt & Hess 5 with no improvement ICP > 30 No plans to treat aneurysm Allergy to Tetracycline / Antibiotics Creatinine >2 Platelets < 75,000 Other brain diseases Previous infection requiring Tetracycline

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br>200 mg IV/placebo Followed by 100 mg IV BID x 7days Followed by 200 mg tablet QD x 14days | Drug: Minocycline<br> <br> |
| Placebo Comparator: Placebo<br>200 mg IV/placebo | Drug: Minocycline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event | The primary objective of the study is to evaluate the effectiveness of minocycline in improving outcomes for patients after aneurysmal SAH. To determine the safety of minocycline 200mg/day for 21 days in the treatment arm after aneurysmal subarachnoid hemorrhage. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparative stroke scale | To demonstrate a significant difference in outcome at 3 months as measured by NIHSS, mRS, BI and GOS in the minocycline treatment group when compared to the placebo arm. To determine any significant differences in vasospasm rates, duration of vasospasm, interventions for vasospasm, vasospasm related infarcts and delayed ischemic deficits between minocycline and placebo arms | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SAH