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Trial record 39 of 195 for:    Hemorrhage AND SAH

Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02113176
Recruitment Status : Unknown
Verified April 2014 by Adnan H. Siddiqui, University at Buffalo.
Recruitment status was:  Recruiting
First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Collaborator:
University at Buffalo Neurosurgery
Information provided by (Responsible Party):
Adnan H. Siddiqui, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Subarachnoid Aneurysm Hemorrhage Drug: Minocycline Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Bleeding

Arm Intervention/treatment
Experimental: Minocycline
  • 200 mg IV/placebo
  • Followed by 100 mg IV BID x 7days
  • Followed by 200 mg tablet QD x 14days
Drug: Minocycline
Placebo Comparator: Placebo



Primary Outcome Measures :
  1. adverse event [ Time Frame: 21 days ]

    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.



Secondary Outcome Measures :
  1. comparative stroke scale [ Time Frame: 3 months ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113176


Locations
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United States, New York
University of Buffalo Neurosurgery Recruiting
Buffalo, New York, United States, 14203
Contact: Jennifer Gay, B.S., CCRP    716-888-4811    jgay@ubns.com   
Contact: Jenna McAdoo, M.S.    716-888-4807    jmcadoo@ubns.com   
Principal Investigator: Adnan Siddiqui, M.D, PhD         
Sponsors and Collaborators
University at Buffalo
University at Buffalo Neurosurgery

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Responsible Party: Adnan H. Siddiqui, Associate Professor of Neurosurgery & Radiology, Director of Neurosurgical Research, Director of Stroke Service, University at Buffalo
ClinicalTrials.gov Identifier: NCT02113176     History of Changes
Other Study ID Numbers: MINO-SAH
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Keywords provided by Adnan H. Siddiqui, University at Buffalo:
SAH

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents