Cerebral Aneurysm Clinical Trial
Official title:
The Role of Remote Ischemic Preconditioning in the Prevention of Ischemic Brain Damage During Intracranial Aneurysm Treatment (RIPAT) - A Prospective Randomized Exploratory Study
The RIPAT study is a prospective, randomized, double-blind study organized by the neurovascular group of the Clinical Department of Neurosurgery of Innsbruck Medical University, Innsbruck, Austria. Patients aged 18+ in whom the treatment of an un-ruptured intracranial aneurysm is indicated are eligible for study participation. Prior to aneurysm treatment, with the patient already under general anesthesia, the blood supply to an arm will be restricted for 3x 5minutes by inflating a standard blood pressure cuff. The study hypothesis is that this "remote ischemic preconditioning" maneuver is able to prevent a stroke during the following treatment of the aneurysm.
Prospective, randomized, double-blind, explorative single center clinical trial in patients
subjected to the treatment of an un-ruptured intracranial aneurysm, either by surgical
clipping or endovascular coiling. Goal of the study is to determine whether remote ischemic
preconditioning (RIPC) prior to aneurysm treatment alters various biomarkers associated with
ischemic central neuronal tissue damage. The trial takes place at Innsbruck University
Hospital of Innsbruck Medical University, Innsbruck, Austria.
Patients fulfilling inclusion criteria are randomly allocated either to pre-interventional
ischemic preconditioning (Group A = intervention group) or sham preconditioning (Group B =
control group). RIPC is performed by inflating a blood pressure cuff around one upper
extremity three times for five minutes with five minutes interval with the patient under
general anesthesia prior to the start of the procedure.
Patients, all staff involved in diagnosis and treatment and all study members are blinded to
the patients' group affiliation. The anesthesiologist and two staff members who perform
preconditioning are not blinded.
Primary outcome is a difference of ± 2SD in the concentration-time curve of a panel of
biochemical parameters indicative of cerebral ischemia (S100B, NSE, GFAP, MMP9, MBP,
microparticles) in the first five days after the intervention. Secondary outcome parameters
are changes in the post-interventional MRI and neuropsychological and clinical outcome at
six and 12 months.
CONSORT and TIDieR guidelines will be followed. The trail will be registered in a public
database. The trail protocol will be published in an open-access journal.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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