Subarachnoid HemorrhageNCT02320539
MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
An observational study of Subarachnoid Hemorrhage and Delayed Cerebral Ischemia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Acute Lung Injury
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to May 2015
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1-2: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated with external ventricular drain. Group 3: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated without external ventricular drain. Group 4: Healthy blood donors
Who may be able to join
- Uncertainty < 24 times on time of ictus
- Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain.
- Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain.
Who cannot join
- Transfer to other hospital within 5 days of admission
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.
Read the detailed description
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to validate former results from CSF studies through microRNA profiling investigate the pathophysiological mechanisms that lead to systemic complications such as cardiac dysfunction, acute lung injury (ALI) and systemic inflammatory response syndrome(SIRS).
We will accomplish this through analyzing the profile of microRNA expression in blood and cerebrospinal fluid from SAH patients.
Validation:
As in our earlier study we wish to compare the expression of 20 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus. In addition, some of the patients will have established invasive neuromonitoring including microdialysis in which we will study changes of certain microRNAs.
DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:
"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components [eye, motor on either side, verbal]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."
Systemic complications:
Furthermore, we wish to compare the expression of 754 specific microRNA in blood drawn on day 3 after ictus between patients with ALI (as described Kahn et al, Crit Care Med. 2006; 34: 196-202) and patients without ALI. Of at least 36 patients expected to be included 12 should statistically develop ALI according to the referred definition.
Additionally, we wish to compare the expression of 754 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in blood drawn on day 3 after ictus.
Moreover, we wish to compare the expression of 754 specific microRNA in blood between 36 patients (group 1-3) to that of healthy controls. The specific microRNAs of interest in which the expression in blood between patients with systemic complication are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.
- Conditions
- Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Acute Lung Injury, Cardiac Dysfunction, Systemic Inflammatory Response Syndrome
- Keywords
- MicroRNA, Cerebrospinal fluid
- Medical subject headings
- Subarachnoid Hemorrhage, Acute Lung Injury, Systemic Inflammatory Response Syndrome
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 |
|---|---|---|
| SAH with DCI | After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia. | |
| SAH without DCI | After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia. | |
| SAH good grade | SAH without external ventricular drainage | |
| Healthy controls | Blood sample in healthy donors registered in the National Donor Registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Cerebral Ischemia
Delayed Cerebral Ischemia as defined by Vergouwen et al[1]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures.
Comparing microRNA profiles between groups with or without.
Measured: 21 days
Delayed Cerebral Ischemia and Cerebral infarction
as defined by Vergouwen et al [1].
Comparing microRNA profiles between groups with or without.
Measured: 21 days
Delayed Cerebral infarction
as defined by Vergouwen et al [1].
Comparing microRNA profiles between groups with or without.
Measured: 21 days
Secondary outcomes (4)
Acute Lung Injury
as defined by Kahn et al[2].
Comparing microRNA profiles between groups with or without
Measured: 21 days
Cardiac Dysfunction
Evaluated by transthoracic echocardiography
Comparing microRNA profiles between groups with or without
Measured: 21 days
Systemic Inflammatory Response Syndrome
Evaluated through daily vital signs and biochemistry
Comparing microRNA profiles between groups with or without
Measured: 21 days
Early Brain Injury
Early Brain injury = GCS 3-12 and/or paresis (degree 4) of at least one extremity or aphasia No Early Brain injury = GCS 13-15 and no or only small and mild focal deficit
Comparing microRNA profiles between groups with or without
Measured: Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren Bache, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten Møller, Prof, Study director, Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320539
- Sponsor's protocol ID
- H-6-2014-073
- Status last verified
- May 2015
- First submitted
- 28 Oct 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matzen JS, Krogh CL, Forman JL, Garred P, Moller K, Bache S. Lectin complement pathway initiators after subarachnoid hemorrhage - an observational study. J Neuroinflammation. 2020 Nov 12;17(1):338. doi: 10.1186/s12974-020-01979-y.
PubMed 33183322
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
- ClinicalTrials.gov ID
- NCT02320539
- Acronym / sponsor ID
- H-6-2014-073
- Conditions
- Subarachnoid Hemorrhage, Delayed Cerebral Ischemia, Acute Lung Injury, Cardiac Dysfunction, Systemic Inflammatory Response Syndrome
- Keywords
- MicroRNA, Cerebrospinal fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 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.
The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.
Detailed description
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to validate former results from CSF studies through microRNA profiling investigate the pathophysiological mechanisms that lead to systemic complications such as cardiac dysfunction, acute lung injury (ALI) and systemic inflammatory response syndrome(SIRS).
We will accomplish this through analyzing the profile of microRNA expression in blood and cerebrospinal fluid from SAH patients.
Validation:
As in our earlier study we wish to compare the expression of 20 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus. In addition, some of the patients will have established invasive neuromonitoring including microdialysis in which we will study changes of certain microRNAs.
DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:
"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components [eye, motor on either side, verbal]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."
Systemic complications:
Furthermore, we wish to compare the expression of 754 specific microRNA in blood drawn on day 3 after ictus between patients with ALI (as described Kahn et al, Crit Care Med. 2006; 34: 196-202) and patients without ALI. Of at least 36 patients expected to be included 12 should statistically develop ALI according to the referred definition.
Additionally, we wish to compare the expression of 754 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in blood drawn on day 3 after ictus.
Moreover, we wish to compare the expression of 754 specific microRNA in blood between 36 patients (group 1-3) to that of healthy controls. The specific microRNAs of interest in which the expression in blood between patients with systemic complication are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAH with DCI | – | –After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia. |
| SAH without DCI | – | –After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia. |
| SAH good grade | – | –SAH without external ventricular drainage |
| Healthy controls | – | –Blood sample in healthy donors registered in the National Donor Registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1-2: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated with external ventricular drain. Group 3: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated without external ventricular drain. Group 4: Healthy blood donors
Key inclusion criteria (3 listed)
- Uncertainty < 24 times on time of ictus
- Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain.
- Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain.
Key exclusion criteria (1 listed)
- Transfer to other hospital within 5 days of admission
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
Delayed Cerebral Ischemia
Time frame: 21 days
Delayed Cerebral Ischemia as defined by Vergouwen et al[1]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures. Comparing microRNA profiles between groups with or without.
Delayed Cerebral Ischemia and Cerebral infarction
Time frame: 21 days
as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without.
Delayed Cerebral infarction
Time frame: 21 days
as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without.
4 secondary outcomes
Acute Lung Injury
Time frame: 21 days
Cardiac Dysfunction
Time frame: 21 days
Systemic Inflammatory Response Syndrome
Time frame: 21 days
Early Brain Injury
Time frame: Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)
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 27 May 2015.
- Derived from this study: PubMed 33183322Matzen JS, Krogh CL, Forman JL, Garred P, Moller K, Bache S. Lectin complement pathway initiators after subarachnoid hemorrhage - an observational study. J Neuroinflammation. 2020 Nov 12;17(1):338. doi: 10.1186/s12974-020-01979-y.
- \[1\] Vergouwen et al in Stroke 2010;41(10):2391-2395.Link provided by the sponsor.
- \[2\] Kahn et al, Crit Care Med, Vol. 34, No.1 2006Link provided by the sponsor.
Related trials for Subarachnoid Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage
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.
Kirsten Møller, Prof study director
Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet
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 and Delayed Cerebral Ischemia, run by Copenhagen University Hospital, Rigshospitalet 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 3 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 27 May 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 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?
Delayed Cerebral Ischemia (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320539, which also lists 1 linked publication.
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 27 May 2015.