Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients

2015-07-28 13:53:55 | BioPortfolio


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.


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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Cerebral Aneurysm




Not yet recruiting


Lawson Health Research Institute

Results (where available)

View Results


Published on BioPortfolio: 2015-07-28T13:53:55-0400

Clinical Trials [1037 Associated Clinical Trials listed on BioPortfolio]

Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients

This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection comp...

Risk Factors for Occurrence of the Middle Cerebral Artery Aneurysm

The aim of the research was to evaluate independent risk factors for the presence of middle cerebral artery aneurysm. Hemodynamic factors play the most important role in rupture aneurysm a...

Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1

In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operati...

Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm

Rupture of a cerebral aneurysm is a serious medical condition that may result in permanent disability or even death just related to the aneurysm rupture itself. Patients who undergo succe...

The Clinical Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia

The first purpose of this study is to find out the clinical benefit and risk of oral aspirin for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in patien...

PubMed Articles [2270 Associated PubMed Articles listed on BioPortfolio]

In vivo cerebral aneurysm models.

Cerebral aneurysm rupture is a devastating event resulting in subarachnoid hemorrhage and is associated with significant morbidity and death. Up to 50% of individuals do not survive aneurysm rupture, ...

Blind date with an aneurysm- Case report of an acute M1 middle cerebral artery thrombus with native CT scan suggesting MCA aneurysm rupture.

We present the case of a concurrent rupture of a middle cerebral artery (MCA) aneurysm and thrombosis of the associated vessel.

Tulip Giant Aneurysm Amputation and "Shingle Clip Cut Clip" Technique for Microsurgical Reconstruction of a Giant Thrombosed Middle Cerebral Artery Aneurysm.

In this video, we present the case of a 61-year-old female who was brought to the emergency room after she had partial complex seizures. CT and MRI of the brain revealed a right temporal lobe mass whi...

Evaluation of Surgical Procedures that Affect the Hemodynamics Using the FloTrac System in Esophageal Cancer Patients.

Esophagectomy is more invasive compared to other gastrointestinal surgery types. Perioperative circulatory management is important to avoid postoperative heart complications. The FloTrac sensor along ...

Significance of CT perfusion examination of cerebral blood flow for assessing the risk of brain ischemia in patients with intracranial arterial aneurysm ruptures.

Prognosing the outcome of cerebral ischemia in the acute SAH phase still remains the topical issue for clinical practice because this largely affects the choice of an optimal timing of aneurysm clippi...

Medical and Biotech [MESH] Definitions

Bleeding within the CEREBRAL VENTRICLES. It is associated with intraventricular trauma, aneurysm, vascular malformations, hypertension and in VERY LOW BIRTH WEIGHT infants.

Aneurysm due to growth of microorganisms in the arterial wall, or infection arising within preexisting arteriosclerotic aneurysms.

Not an aneurysm but a well-defined collection of blood and CONNECTIVE TISSUE outside the wall of a blood vessel or the heart. It is the containment of a ruptured blood vessel or heart, such as sealing a rupture of the left ventricle. False aneurysm is formed by organized THROMBUS and HEMATOMA in surrounding tissue.

Aneurysm of the MICROVASCULATURE. Charcot–Bouchard aneurysms are aneurysms of the brain vasculature which is a common cause of CEREBRAL HEMORRHAGE. Retinal microaneurysm is an early diagnostic sign of DIABETIC RETINOPATHY.

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

More From BioPortfolio on "Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients"

Quick Search

Relevant Topics

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Anesthesia is the loss of feeling or sensation in all or part of the body. It may result from damage to nerves or can be induced by an anesthetist (a medical professional) using anesthetics such as thiopental or propofol or sevoflurane during a surgical ...

Searches Linking to this Trial