Clinical Trials

Genetic Risks for Medication-Related Hemorrhagic Stroke (GOCHA)

Description

Status: Open to Enrollment

Start Date: Oct 12 2007

End Date: Jul 31 2013

Objectives:

The GOCHA study is multi-site study funded by the National Institute of Health (NIH).

The goal of this multi-center study is to examine potential genetic risk factors for intracerebral hemorrhage (ICH) in patients taking anticoagulant medication.

Participant Eligibility

Ages Eligible for Study: > 55
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Case Subjects

Inclusion Criteria

  • Symptomatic ICH, sufficiently severe to cause the patient to seek medical attention
  • Age >55, either gender. There is no upper age limit to participation.
  • Ability and willingness of patient, family member, or legal guardian to provide informed consent
  • Patient taking warfarin (for any indication) at the time of ICH with INR at presentation > 1.4 are classified as warfarin-exposed.
Exclusion Criteria
  • Patient taking heparin (for any indication) at the time of ICH.
  • Concussive head trauma during the 24 hours before ICH presentation (unless trauma was clearly a result of the ICH, e.g. head trauma resulting from a seizure caused by acute ICH)
  • Radiographic or pathological demonstration of any of the following
    *ischemic stroke, occurring during the 2 weeks prior to ICH presentation
    *primary or metastatic intracerebral tumor
    *intracerebral vascular malformation
    *vasculitis of the central nervous system
  • Antecedent use of cocaine or sympathomimetic drug
  • Antecedent alcohol abuse (defined as >8 drinks in the previous 24 hours or >28 drinks over the previous week)
  • History of a primary coagulopathy, blood dyscrasia, or active liver disorder
  • Greater than 1 week interval between onset of symptoms and presentation to enrolling center

Control Subjects

Inclusion Criteria

  • As above for ICH patients, with the exception that subjects will not have had symptomatic ICH.

Exclusion Criteria

  • History of symptomatic ICH
  • Initial INR at presentation of < 1.4
  • Antecedent use of cocaine or sympathomimetic drug
  • Antecedent alcohol abuse (defined as >8 drinks in the previous 24 hours or >28 drinks over the previous week)
  • History of a primary coagulopathy, blood dyscrasia, or active liver disorder

Sponsors and Collaborators:

Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)

Study Chair:

Jonathan Rosand, MD Massachusetts General Hospital


Principal Investigators

Jennifer Majersik, M.D.

Co Investigators

Robert Hoesch, M.D.

Contact Information

Name: Julie Martinez RN, BSN
Phone: 801-585-7027
Email: julie.martinez@utah.edu

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