Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage

NCT ID: NCT01406457

Last Updated: 2015-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Subarachnoid Hemorrhage

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Jed Hartings

Research Asst Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jed Hartings, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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10-04-21-01

Identifier Type: -

Identifier Source: org_study_id

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