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Trial record 2 of 6 for:    04-21

Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage (MODISH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406457
First Posted: August 1, 2011
Last Update Posted: October 21, 2015
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.
Information provided by (Responsible Party):
Jed Hartings, University of Cincinnati
  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

Resource links provided by NLM:


Further study details as provided by Jed Hartings, University of Cincinnati:

Biospecimen Description:
No specimens are to be retained.

Enrollment: 7
Study Start Date: June 2010
Study Completion Date: March 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01406457


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Jed Hartings, PhD University of Cincinnati
  More Information

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
First Submitted: July 28, 2011
First Posted: August 1, 2011
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by Jed Hartings, 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