Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment (RIPAT)
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|ClinicalTrials.gov Identifier: NCT02162654|
Recruitment Status : Unknown
Verified June 2014 by Martin Ortler, MD MSc, Medical University Innsbruck.
Recruitment status was: Recruiting
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Aneurysm||Procedure: Remote ischemic preconditioning Procedure: Sham preconditioning||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2016|
Active Comparator: Remote ischemic preconditioning
Inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment
Procedure: Remote ischemic preconditioning
The blood pressure cuff is inflated to 200 mmHg for 3 x 5 minutes with 5 minutes of reperfusion by complete cuff deflation each.
Sham Comparator: Sham preconditioning
Sham inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment
Procedure: Sham preconditioning
The blood pressure cuff is inflated to 10 mmHg for 3 x 5 minutes with 5 minutes of complete cuff deflation each.
- Area-under-Curve for biomarkers in the first 5 days after aneurysm treatment(S100B, NSE, GFAP, NSE, MMP9, Microparticles) [ Time Frame: on admission, after preconditioning but prior to intervention, at completion of intervention, at hours 3, 6, 12, 24, 48, 72, 96, 120 after completion of intervention ]Serum biomarkers reflect brain tissue ischemic damage with various specificity and sensitivity (see Whiteley 2008, Ahmad 2012) Advantages include (1) to be available early, (2) to be continuous variables (low study n), (3) they were able to demonstrate an effect of ischemic preconditioning in other clinical studies (see Koch 2010, Veighei 2012)
- Number (n) of new lesions in postinterventional MRI (DWI and FLAIR) [ Time Frame: preinterventional/on day 1 or 2 ]Outcome Parameter used in other clinical studies focussing on ischemia after neurointerventional procedures (e.g. ENACT study)
- Clinical outcome ( National Institutes of Health Stroke Scale, NIHSS and modified Rankin Scale mRS) [ Time Frame: at discharge, at 6 and 12 months ]Established outcome parameters for cerebrovascular studies. Dichotomized into favourable (NIHSS ≤1, mRS 0-1) and unfavourable
- Volume (mm3) of new lesions in postinterventional MRI (DWI and FLAIR) [ Time Frame: preinterventional, postinterventional on day 1 or 2 ]As above for number of lesions
- Neuropsychological testing VLMTA (Verbaler Lern- und Merkfähigkeitstest), the WMS-R (Zahlenspanne vorwärts und rückwärts), trail making A and B tests, the Regensburger Wortflüssigkeitstest, the TAP Wechsel verbal, the TAP and the HADS-D) [ Time Frame: preinterventional, at 6 and 12 months ]Standard tests used in patients with cerebrovascular disorders in our departments. Not applicable to non-german-speaking patients.
- Brain volume changes (MRI, voxel -based morphometry) [ Time Frame: Preinterventional/at the 12 months FU ]Longterm brain volume changes that correlate with NP deficits (Horstmann 2010, Moskowitz 2011, Vuylsteke 2011) will be analyzed using voxel-based morphometry techniques
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162654
|Contact: Martin Ortler, M.D., MSc.||0043-512-504 ext firstname.lastname@example.org|
|Contact: Claudius Thomé, M.D.||0043-512-504 ext email@example.com|
|Clinical Department of Neurosurgery, Innsbruck Medical University||Recruiting|
|Innsbruck, Austria, 6020|
|Contact: Martin Ortler, M.D., MSc. 0043-512-504 ext 80975 firstname.lastname@example.org|
|Contact: Selma Tülü, Cand. med. email@example.com|
|Principal Investigator: Martin Ortler, MD, MSc|
|Sub-Investigator: Claudius Thomé, M.D.|
|Sub-Investigator: Selma Tülü, Cand.med.|
|Sub-Investigator: Miriam Mulino, M.D.|
|Sub-Investigator: Daniel Pinggera, M.D.|
|Sub-Investigator: Claudia Unterhofer, M.D.|
|Sub-Investigator: Erich Schmutzhard, M.D.|
|Sub-Investigator: Bettina Pfausler, M.D.|
|Sub-Investigator: Ronny Beer, M.D.|
|Sub-Investigator: Raimund Helbok, M.D.|
|Sub-Investigator: Peter Lackner, M.D.|
|Sub-Investigator: Thomas Benke, M.D.|
|Sub-Investigator: Thomas Bodner, M.D.|
|Sub-Investigator: Margarethe Delazer, M.D.|
|Sub-Investigator: Raffaella Matteucci-Gothe, Ph.D.|
|Sub-Investigator: Uwe Siewert, Ph.D.|
|Sub-Investigator: Philipp Würtinger, M.D.|
|Sub-Investigator: Andrea Griesmacher, M.D.|
|Sub-Investigator: Markus Luger, M.D.|
|Sub-Investigator: Arnulf Benzer, M.D.|
|Sub-Investigator: Franz Wiedermann, M.D.|
|Sub-Investigator: Astrid Grams, M.D.|
|Sub-Investigator: Elke Gizewski, M.D.|
|Principal Investigator:||Martin Ortler, M.D., MSc.||Clinical Department of Neurosurgery, Innsbruck Medical University|