Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients

Learn more about:
Related Clinical Trial
Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms Intraoperative Fluorescence With Augmented Reality Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) Amnesia After Surgery for Anterior Communicating Aneurysm: High Resolution Magnetic Resonance (MR) Imaging Findings Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy Esmolol Infusion in Patients Undergoing Craniotomy Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing. Registry for Study of Coils in Intracranial Aneurysms EEG Monitoring to Assess Emergence From Neuroanesthesia DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial Hydrogel Endovascular Aneurysm Treatment Trial Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage Estrogen Therapy as Prevention in the Progression of Aneurysm (EPPA) Trial Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment Doppler Flow Wires in Cerebral Angiography Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity Use of Classic LMA During Endovascular Therapy HydroCoil Cerebral Aneurysm Treatment Trial Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 Decision Aids in Cerebral Aneurysm Treatment Framing Eighteen Coils in Cerebral Aneurysms Trial Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

Brief Title

Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients

Official Title

Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients - A Prospective, Blinded Randomized Controlled Trial

Brief Summary

      Goal directed therapy (GDT) is a technique, which employs a non-invasive cardiac output
      monitoring (NICOM) device to guide management of circulating blood volume and blood pressure
      during procedures. The purpose of this study is to determine whether the use of goal-directed
      therapy to optimize blood volume and cardiac output during the procedure can improve the
      outcome of patients undergoing endovascular treatment of a brain aneurysm.
    

Detailed Description

      Subarachnoid hemorrhage (SAH) as a result of ruptured intracranial cerebral aneurysms is a
      life threatening condition; with an estimated incidence of 6-10 cases per 100,000 persons per
      year. Endovascular coil emobolization of the aneurysm is performed to isolate the aneurysm
      and reduce the risk of re-bleeding. Unfortunately, despite timely and successful intervention
      approximate 25% of post-coiling patients suffer immediate and/or long-term injury including
      death as a result of intracranial bleeding. This is mainly a consequence of subarachnoid
      hemorrhage-related complications , especially cerebral vasospasm. Angiographic vasospasm and
      symptomatic vasospasm occur in 30-70% and 20-30% of SAH patients respectively. Goal-directed
      therapy (GDT) provides a means to assess and manage circulating volume and cardiac output. In
      this study, the investigators would investigate the use of GDT during aneurysm coiling
      procedures can improve the clinical course of these patients.

      This will be a blinded, randomized pilot study to compare clinical outcomes for endovascular
      coiling patients allocated to one of two treatments: GDT or non-GDT. Randomization consented
      patients will be randomized into GDT or non-GDT groups in 1:1 ratio. The attending
      anesthesiologists will not be blinded because of the nature of the intervention. However,
      surgeons, patients, outcomes assessors will be blinded as to the treatment intervention.

      In all patients, an arterial catheter (routinely used in these patients) will be inserted and
      connected to the Flotrac (Edward Lifesciences). After transferring the patients into the
      angiogram suite, routine monitoring such as pulse oximetry, electrocardiography, non-invasive
      blood pressure monitoring, end-tidal CO2 and temperature probe will be attached to the
      patients. Anesthesia will be conducted in the standard fashion. Patients will be randomized
      into two groups in 1:1 ratio: GDT or non-GDT therapy.

        -  GDT group: the attending anesthesiologist will use the data obtained from the Flotrac to
           manage fluid and hemodynamics during the procedure following the prescribed treatment
           algorithm. The treatment interventions will start on induction of anesthesia and
           continue until the patients are extubated or transferred back to intensive care unit
           with mechanical ventilation.

        -  Non-GDT group: Flotrac will be connected but the machine values will be blinded to the
           anesthesiologist and interventionist. The screens of the Flotrac will be covered by
           opaque plastic bag and the alarms will be turned off. The attending anesthesiologist
           will make clinical decisions regarding the management of fluids and hemodynamics based
           on current individual routine practices.
    


Study Type

Interventional


Primary Outcome

Composite outcomes of cerebral vasospasm, stroke and death

Secondary Outcome

 Composite outcomes of all perioperative complications

Condition

Cerebral Aneurysm

Intervention

Flotrac

Study Arms / Comparison Groups

 Goal Directed Therapy - Flotrac Use Arm
Description:  This arm will employ the use of the Flotrac device to monitor cardiac output, cardiac index, stroke volume, stroke volume variation, and blood pressure management.

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

Device

Estimated Enrollment

40

Start Date

November 2015

Completion Date

February 2019

Primary Completion Date

February 2019

Eligibility Criteria

        Inclusion Criteria:

          -  All adult patients (age> 18 years of age) scheduled for aneurysm endovascular coiling
             procedures over the next 2 years.

          -  Grade I to IV SAH within 5 days of presentation will be included in the study.

          -  Only patients identified as appropriate by the neurosurgeon/neuro-radiologist will be
             recruited.

        Exclusion Criteria:

        - Patients with un-ruptured aneurysm(s)

          -  Patients with previous clipping or coiling procedure for the same aneurysm.

          -  Patients undergoing concomitant extracranial-intracranial bypass procedures or other
             non-neurosurgical procedures.

          -  Patients with giant aneurysm (size> 25mm)

          -  Pediatric patients (<18 years of age) or pregnant patients

          -  Unable to obtain informed consent from patients or substitute decision maker (SDM).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jason Chui, MBChB, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02507999

Organization ID

GDT


Responsible Party

Principal Investigator

Study Sponsor

Lawson Health Research Institute


Study Sponsor

Jason Chui, MBChB, Principal Investigator, Assistant Professor, Western Unviersity


Verification Date

March 2019