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Subarachnoid HemorrhageNCT01791257

MicroRNA Diagnostics in Subarachnoid Hemorrhage

An observational study of Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subarachnoid Hemorrhage
Type of treatment
Injection or infusion
How many people
50 participants
Where
2 sitesDenmark
Study dates
Feb 2013to Jan 2014
How long will I take part?
3 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Group 1+2: Patients admitted to Neurointensive Department in Rigshospitalet. Group 3: Patients undergoing spinal anesthesia for orthopedic surgery in Bispebjerg Hospital.

Who may be able to join

  • Patient admitted to the neurointensive care unit with aneurismal subarachnoid hemorrhage
  • External ventricular drainage with 5 days of ictus
  • Age > 18 years

Who cannot join

  • Glasgow Coma Score (GCS) continuously < 7 during the first 5 days following ictus
  • A known and proven complication (rebleeding, clip/coil complication, cardiopulmonal complication requiring full sedation, ventriculitis e.g.) leads to a GCS < 7 thereby preventing the detection of DCI.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 1302

  • Bispebjerg Hospital

    Copenhagen, 2400

Other trials in Denmark

About this study

Official title: MicroRNA Expression in Cerebrospinal Fluid From Patients Suffering Subarachnoid Hemorrhage With and Without Delayed Cerebral Ischemia

The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.

Read the detailed description

In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (DCI).

We will accomplish this through analyzing the profile of microRNA expression in the cerebrospinal fluid of SAH patients treated with extraventricular drainage.

At first we wish to compare the expression of 376 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.

Secondly specific microRNAs of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.

Should we find no differently expressed specific microRNAs we will compare the expression of microRNA in group 1+2 with group 3.

In addition, some of the patients as part of another clinical trial (NCT01447095

) will have established invasive neuromonitoring including microdialysis. It is our intention to develop a method for analyzing microRNA in this microdialysate.

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."

Keywords
delayed, cerebral, ischemia, microrna, cerebrospinal fluid, subarachnoid, hemorrhage
Medical subject headings
Subarachnoid Hemorrhage, Ischemia, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01791257
Study groupRoleWhat they receive
SAH with DCIAfter 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 DCIAfter 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
Neurological healthy controls12 patients (ASA 1) undergoing spinal anesthesia for orthopedic surgery have 2 ml of cerebrospinal fluid drawn preceding injection of local analgetic.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delayed Cerebral Ischemia - Clean groups

    Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

    We found confirmation/exclusion of DCI difficult in a few patients. To minimize error, two clinicians reviewed all clinical, biochemical and radiological data, obtained 3 weeks from ictus, and independently assessed if any clinical deterioration fulfilled the criteria of delayed cerebral ischemia. Furthermore, included patients were categorized as "definitely DCI", "probably DCI", "probably not DCI" or "definitely not DCI".

    Therefore we decided to modify our primary outcome measure in this case-control study to compare "definitely DCI" vs. "definitely not DCI".

    Measured: 21 days

Secondary outcomes (5)

  1. Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm

    Comparison of 667 specific microRNAs in CSF at day 5 after ictus between two groups of SAH-patients depending on their clinical neurology at the first wake-up call following occlusion of the aneurysm:

    1. GCS 3-12 and/or (paresis (degree 4) of at least one extremity or aphasia)
    2. GCS 13-15 and no or only small and mild focal deficit

    Measured: Assessed at the first wake-up call following clip or coil

  2. Association of microRNA-profile with 3 month outcome

    Comparison of 667 specific microRNAs in CSF at day 5 after ictus between two groups of SAH-patients depending on their mRS at 3 month follow-up in groups:

    1. mRS = 3-6
    2. mRS = 0-2

    Measured: Follow up examination at 3 month or as close to this

  3. Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups.

    Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

    In contrast to our primary outcome measure, these groups will include patients where DCI was difficult to exclude or confirm.

    Thereby we wish to compare "definitely DCI" and "probably DCI" vs. "probably not DCI" and "definetly not DCI". This would enable comparison between larger groups though less clean.

    Measured: 21 days following ictus

  4. Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

    The presence of cerebral infarction on CT or MR scan of the brain within 6 weeks after SAH, or on the latest CT or MR scan made before death within 6 weeks, or proven at autopsy, not present on the CT or MR scan between 24 and 48 hours after early aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities on CT imaging resulting from ventricular catheter or intraparenchymal hematoma should not be regarded as cerebral infarctions from DCI.

    Measured: Following a blinded description of CT-scans

  5. Relation of microRNA profile to the regional area of cerebral injury

    As microRNAs seem to be specific for different areas of the brain our screening might tell us which area has sustained injury and which has not. This study will not include two groups as the secondary outcome measures above.

    Measured: Following a blinded description of CT-scans

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

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
50 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01791257
Sponsor's protocol ID
MicroRNA in SAH
Status last verified
Apr 2014
First submitted
12 Feb 2013
Last updated
8 Apr 2014
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

  • Bache S, Rasmussen R, Rossing M, Laigaard FP, Nielsen FC, Moller K. MicroRNA Changes in Cerebrospinal Fluid After Subarachnoid Hemorrhage. Stroke. 2017 Sep;48(9):2391-2398. doi: 10.1161/STROKEAHA.117.017804. Epub 2017 Aug 2.

    PubMed 28768799

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 2 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 - Clean groups (time frame: 21 days). 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 NCT01791257, which also lists 2 linked publications.

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 8 Apr 2014.

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