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Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage (MODISH)

This study is currently recruiting participants.
Verified July 2012 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Jed Hartings, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01406457
First received: July 28, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

The goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain.


Condition
Subarachnoid Hemorrhage

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage

Further study details as provided by University of Cincinnati:

Biospecimen Description:

No specimens are to be retained.


Estimated Enrollment: 15
Study Start Date: June 2010
Detailed Description:

Patients who suffer from a bleeding in the brain (stroke or hemorrhage) often experience secondary complications that can occur up to 2 weeks after the initial bleeding. Complications can include decrease of consciousness, weakness or paralysis, difficulty with speech and language, and worsening of brain damage. These decrease a patient's chances for a good recovery. A brain scan will be used to determine the damage caused by the bleeding, and the brain's electrical activity will be monitored to detect abnormal activity. These measures will be analyzed together with routine medical information to better understand and diagnose complications.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with subarachnoid hemmorhage clinical symptoms

Criteria

Inclusion Criteria:

  1. Age 18 to 70 years
  2. World Federation of Neurosurgery (WFNS) grade III-IV, and grade V patients who improve within 24h after ventriculostomy
  3. Diffuse thick or localized thick subarachnoid clot >1 mm on baseline CT (Fisher grade 3-4)
  4. Ruptured saccular aneurysm demonstrated by CT-angiography or DSA
  5. Onset of aSAH clinical symptoms within the preceding 72h
  6. Treatment of aneurysm within 24 h after admission
  7. Treatment of aneurysm by clip ligation

Exclusion Criteria:

  1. SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm)
  2. Only a thin diffuse layer or no visible subarachnoid blood in the initial CT
  3. Admission in a clinical state with unfavourable prognosis (e.g., bilateral dilated, non-reactive pupils for more than 1h)
  4. Coagulopathy (thrombocytes <60,000/ml or INR>1.5)
  5. Pregnancy
  6. Presence of incompatibilities for MRI, such as non-removable metals, artificial joints, electronic devices (pace maker, pumps), etc.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406457

Contacts
Contact: Carolyn Koenig, RN (513) 558-3518 carolyn.koenig@uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Carolyn Koenig, RN     513-558-3518     carolyn.koenig@uc.edu    
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Jed Hartings, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Jed Hartings, Research Asst Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01406457     History of Changes
Other Study ID Numbers: 10-04-21-01
Study First Received: July 28, 2011
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Cincinnati:
Subarachnoid Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Ischemia
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013