Trial record 17 of 772 for:
Open Studies | "Hemorrhage"
Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage (MODISH)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Cincinnati.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Jed Hartings, University of Cincinnati
First received: July 28, 2011
Last updated: July 17, 2012
Last verified: July 2012
The goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain.
||Observational Model: Case-Only
Time Perspective: Prospective
||Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage
No specimens are to be retained.
| Estimated Enrollment:
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with subarachnoid hemmorhage clinical symptoms
- Age 18 to 70 years
- World Federation of Neurosurgery (WFNS) grade III-IV, and grade V patients who improve within 24h after ventriculostomy
- Diffuse thick or localized thick subarachnoid clot >1 mm on baseline CT (Fisher grade 3-4)
- Ruptured saccular aneurysm demonstrated by CT-angiography or DSA
- Onset of aSAH clinical symptoms within the preceding 72h
- Treatment of aneurysm within 24 h after admission
- Treatment of aneurysm by clip ligation
- SAH due to other causes (e.g. trauma, fusiform or mycotic aneurysm)
- Only a thin diffuse layer or no visible subarachnoid blood in the initial CT
- Admission in a clinical state with unfavourable prognosis (e.g., bilateral dilated, non-reactive pupils for more than 1h)
- Coagulopathy (thrombocytes <60,000/ml or INR>1.5)
- Presence of incompatibilities for MRI, such as non-removable metals, artificial joints, electronic devices (pace maker, pumps), etc.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01406457
|University of Cincinnati
|Cincinnati, Ohio, United States, 45219 |
|Contact: Carolyn Koenig, RN 513-558-3518 firstname.lastname@example.org |
University of Cincinnati
||Jed Hartings, PhD
||University of Cincinnati
No publications provided
||Jed Hartings, Research Asst Professor, University of Cincinnati
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 28, 2011
||July 17, 2012
||United States: Food and Drug Administration
Keywords provided by University of Cincinnati:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Central Nervous System Diseases
Nervous System Diseases