Cerebral AneurysmNCT02507999
Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients
A study testing Flotrac in people with Cerebral Aneurysm, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Flotrac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients - A Prospective, Blinded Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cerebral Aneurysm
- Being tested
- Flotrac
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlotracDevice
Flotrac guided intervention
| Study group | Role | What they receive |
|---|---|---|
| Goal Directed Therapy - Flotrac Use Arm | Experimental | 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. Receives: Device: Flotrac |
| Non-Goal Directed Therapy | No intervention | In this arm, patients will have the Flotrac machine attached to their arterial catheter but the screen that displays the monitor readings will be covered and machine alarms will be turned off. The anesthesiologist will not be aware of the Flotrac monitor readings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcomes of cerebral vasospasm, stroke and death
To determine if the use of the Flotrac device during surgery is able to decrease the morbidity and mortality rates for 30 days following surgery
Measured: 30 days
Secondary outcomes (3)
Composite outcomes of all perioperative complications
To assess the rate of occurrence of neurological and cardiopulmonary complications that may arise up to 90 days following the participant's surgical procedure. This will be assessed at 7 days, 30 days, and 90 days from the point of study entry.
Measured: 7 days, 30 days, 90 days
Neurological outcomes
Incidence of poor functional neurological outcomes at 7 days, 30 days and 90 days after the procedures.
Measured: 7 days, 30 days, 90 days
Length of hospital stay
Total length of stay in the neuro-critical care unit and in hospital.
Measured: From study entry until hospital discharge, or up to 90 days of after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Chui, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Jason Chui, MBChB, Principal investigator, Assistant Professor, Western Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507999
- Sponsor's protocol ID
- GDT
- Status last verified
- Mar 2019
- First submitted
- 22 Jul 2015
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients - A Prospective, Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02507999
- Acronym / sponsor ID
- GDT
- Conditions
- Cerebral Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Directed Therapy - Flotrac Use Arm | Experimental | Device: FlotracThis arm will employ the use of the Flotrac device to monitor cardiac output, cardiac index, stroke volume, stroke volume variation, and blood pressure management. |
| Non-Goal Directed Therapy | No intervention | –In this arm, patients will have the Flotrac machine attached to their arterial catheter but the screen that displays the monitor readings will be covered and machine alarms will be turned off. The anesthesiologist will not be aware of the Flotrac monitor readings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlotracFlotrac guided intervention | Device | Goal Directed Therapy - Flotrac Use Arm |
Primary outcome
Composite outcomes of cerebral vasospasm, stroke and death
Time frame: 30 days
To determine if the use of the Flotrac device during surgery is able to decrease the morbidity and mortality rates for 30 days following surgery
3 secondary outcomes
Composite outcomes of all perioperative complications
Time frame: 7 days, 30 days, 90 days
Neurological outcomes
Time frame: 7 days, 30 days, 90 days
Length of hospital stay
Time frame: From study entry until hospital discharge, or up to 90 days of after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Chui, MBChB principal investigator
Assistant Professor, Western Unviersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flotrac in people with Cerebral Aneurysm, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcomes of cerebral vasospasm, stroke and death (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.