MicroRNA Diagnostics in Subarachnoid Hemorrhage

NCT01791257 | Completed DMC

• 1 other identifier: MicroRNA in SAH
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subarachnoid Hemorrhage

Keywords

delayed; cerebral; ischemia; microrna; cerebrospinal fluid; subarachnoid; hemorrhage

Outcome Measures

Primary Outcomes (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".

  21 days

Secondary Outcomes (5)

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

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

• Association of microRNA-profile with 3 month outcome

  Follow up examination at 3 month or as close to this

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

  21 days following ictus

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

  Following a blinded description of CT-scans

• Relation of microRNA profile to the regional area of cerebral injury

  Following a blinded description of CT-scans

Study Arms (3)

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.

Neurological healthy controls

12 patients (ASA 1) undergoing spinal anesthesia for orthopedic surgery have 2 ml of cerebrospinal fluid drawn preceding injection of local analgetic.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Bispebjerg Hospital: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 1302, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 33183322 DERIVED

• 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.

  PMID: 28768799 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Group 1+2: Cerebrospinal fluid 1-2 ml a day for 8 days drawn in each patient from external ventricular drain Gropu 3: Cerebrospinal fluid 2 ml drawn from patients undergoing spinal anesthesia before injection of local anesthetic.

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Ischemia; Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Søren B Larsen, MD

  Rigshopsitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Kirsten Møller, DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

DK (2)