Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | January 2010 |
| End Date: | December 2018 |
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.
improving outcomes at 3 months after rupture of an aneurysm in the head.
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.
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.
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
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