Subarachnoid HemorrhageMODISHNCT01406457
Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by University of Cincinnati at 1 site in United States.
Trial summary
The goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subarachnoid hemmorhage clinical symptoms
Who may be able to join
- 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
Who cannot join
- 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)
- Pregnancy
- Presence of incompatibilities for MRI, such as non-removable metals, artificial joints, electronic devices (pace maker, pumps), etc.
Trial locations and contacts
1 site in 1 country.
About this study
The goal in this research is to develop better ways to detect and treat the damage caused by bleeding in the brain.
Read the 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.
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jed Hartings, University of Cincinnati
- Investigators
- Jed Hartings, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406457
- Sponsor's protocol ID
- 10-04-21-01
- Acronym
- MODISH
- Status last verified
- Oct 2015
- First submitted
- 28 Jul 2011
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Delayed Ischemia After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01406457
- Acronym / sponsor ID
- MODISH / 10-04-21-01
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subarachnoid hemmorhage clinical symptoms
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jed Hartings, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.