Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01406457

Acronym

MODISH

Enrollment

Registered

2011-08-01

Start date

2010-06-30

Completion date

2014-03-31

Last updated

2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage

Keywords

Subarachnoid Hemorrhage

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Countries

United States

Outcome results