Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment

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Brief Title

Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment

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

Brief Summary

      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.
    

Detailed Description

      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


Primary Outcome

Area-under-Curve for biomarkers in the first 5 days after aneurysm treatment(S100B, NSE, GFAP, NSE, MMP9, Microparticles)

Secondary Outcome

 Number (n) of new lesions in postinterventional MRI (DWI and FLAIR)

Condition

Cerebral Aneurysm

Intervention

Remote ischemic preconditioning

Study Arms / Comparison Groups

 Remote ischemic preconditioning
Description:  Inflation of a blood pressure cuff around an arm with the patient under general anesthesia prior to start aneurysm treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

48

Start Date

November 2013

Completion Date

November 2016

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Informed written consent of patient

          -  Age > 18 years

          -  Intracranial aneurysm, single or multiple, intervention as indicated by
             interdisciplinary vascular board (includes previously treated aneurysms)

          -  Normal baseline MRI

        Exclusion Criteria:

          -  Clinical or radiological signs of subarachnoid hemorrhage

          -  Planned vessel sacrifice as the primary modality for aneurysm treatment

          -  Dissecting or mycotic aneurysm

          -  Previous history of stroke or TIA within the last six months

          -  Signs or symptoms of upper and lower extremity peripheral vascular illness

          -  Drugs and lifestyle factors that interfere with biomarker Determination

          -  Inability to complete neuropsychological testing for language reasons

          -  Patients unable to have an MRI scan for any reason

          -  Previous serious cerebral disease that would preclude completion of the protocol or
             preclude MRI analysis of small strokes

          -  Pregnancy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Martin Ortler, M.D., MSc., 0043-512-504, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT02162654

Organization ID

20131101-823


Responsible Party

Principal Investigator

Study Sponsor

Medical University Innsbruck


Study Sponsor

Martin Ortler, M.D., MSc., Principal Investigator, Clinical Department of Neurosurgery, Innsbruck Medical University


Verification Date

June 2014