Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage (MODISH)

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

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage

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.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with subarachnoid hemmorhage clinical symptoms

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Jed Hartings, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (Estimate): August 1, 2011

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Subarachnoid Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Ischemia; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 10-04-21-01