Cerebral HemorrhageNCT02326571
Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage
An observational study of Cerebral Hemorrhage, run by Christian Kærsmose Friberg at 1 site in Denmark.
Trial summary
Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to 20 Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for neuro surgery admitted to Rigshospitalet, Copenhagen with spontaneous intracerebral hemorrhage verified by CT.
Who may be able to join
- Diagnosis: spontaneous intracerebral hemorrhage verified by CT
- Clinical indication for craniotomy or craniectomy
- Admitted to the hospital within 24 hours from assumed ictus
- Age over 18 years
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Development of brain edema seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is only understood fragmentarily.
By using multimodal neuro monitoring, the investigators seek to investigate electrophysiological and metabolic processes, which seem to accompany the formation of edema and clinical deterioration in patients suffering from sICH.
- Conditions
- Cerebral Hemorrhage
- Keywords
- EEG, Cortical Spreading Depression, Cerebral Hemorrhage, miRNA, Reactivity in EEG, Multimodal monitoring
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| spontaneous intracerebral hemorrhage | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary brain injury
Assessed by GCS, CAM-ICU, mRS, Imaging, EEG background activity.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion20 Jun 2016
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Kærsmose Friberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Kærsmose Friberg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian K Friberg, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326571
- Sponsor's protocol ID
- H-1-2014-059
- Status last verified
- Apr 2017
- First submitted
- 12 Dec 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT02326571
- Acronym / sponsor ID
- H-1-2014-059
- Conditions
- Cerebral Hemorrhage
- Keywords
- EEG, Cortical Spreading Depression, Cerebral Hemorrhage, miRNA, Reactivity in EEG, Multimodal monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Christian Kærsmose FribergUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 29 Dec 2014 (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.
Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Development of brain edema seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is only understood fragmentarily.
By using multimodal neuro monitoring, the investigators seek to investigate electrophysiological and metabolic processes, which seem to accompany the formation of edema and clinical deterioration in patients suffering from sICH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spontaneous intracerebral hemorrhage | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for neuro surgery admitted to Rigshospitalet, Copenhagen with spontaneous intracerebral hemorrhage verified by CT.
Key inclusion criteria (4 listed)
- Diagnosis: spontaneous intracerebral hemorrhage verified by CT
- Clinical indication for craniotomy or craniectomy
- Admitted to the hospital within 24 hours from assumed ictus
- Age over 18 years
Key exclusion criteria (1 listed)
- 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
Secondary brain injury
Time frame: 10 days
Assessed by GCS, CAM-ICU, mRS, Imaging, EEG background activity.
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 11 Apr 2017.
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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.
Christian K Friberg, MD principal investigator
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 Cerebral Hemorrhage, run by Christian Kærsmose Friberg at 1 site in Denmark.
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 4 inclusion and 1 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 11 Apr 2017. 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 Denmark. 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.
What does the primary outcome measure?
Secondary brain injury (time frame: 10 days). It is what the study was designed to measure, not a finding.
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 11 Apr 2017.