Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— MODISH  

Official title:

Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406457
• Other study ID #: 10-04-21-01
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: October 20, 2015
• Start date: June 2010
• Est. completion date: March 2014

Study information

• Verified date: October 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States,