Clinical trial NCT02113176: Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Subarachnoid Aneurysm Hemorrhage
Keywords: SAH
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: University at Buffalo Neurosurgery
First posted: 2014-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: adverse event
timeFrame: 21 days
Secondary outcomes:
measure: comparative stroke scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University of Buffalo Neurosurgery
state: New York
Study officials:
References: