MicroRNA Diagnostics in Subarachnoid Hemorrhage

Rigshospitalet

Status: Completed

Conditions: Subarachnoid Hemorrhage

Study type: Observational

Funder types: Other

Identifiers

NCT01791257

MicroRNA in SAH

Details and patient eligibility

About

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.

Full 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."

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

50 participants in 3 patient groups

SAH with DCI

Description:

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

Description:

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

Description:

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