Nervous System Diseases

Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Stroke

Ischemic Stroke

Ischemia

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Patients with active solid tumor cancer and acute ischemic stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.

Patients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study.

Patients with active solid tumor cancer and no stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.

Study participants will undergo a single, peripheral blood draw. Blood specimens will be used to perform hematological biomarker testing and leukocyte RNA gene expression analysis.

Hematological biomarker testing will be performed to better elucidate the mechanisms of ischemic stroke in cancer patients and will include markers of coagulation, platelet function, and endothelial integrity. This analysis will occur at MSKCC.

Leukocyte RNA gene expression analysis will be performed to evaluate whether patients with cancer and stroke more often have cardioembolic mechanisms than patients with stroke and no cancer. This analysis will occur at the University of California, Davis where investigators have previously shown that differential RNA expression patterns can predict stroke subtypes.

Blood tests

Study participants will undergo a single Transcranial Doppler Microemboli Detection Study at NYPH/WCMC or MSKCC within two weeks of enrollment. Both middle cerebral arteries will be insonated for 30 minutes by a trained technician or stroke neurologist certified in neurosonology using a fixed headset to assess for the rate and laterality of microemboli.

Transcranial Doppler Microemboli Detection Study

Babak Navi, MD, MS

The purpose of this study is to better understand the causes of stroke in people with cancer. Active cancer increases the risk of stroke. The investigators do not know exactly why this occurs but one possible reason is that people with cancer may have thicker blood than people without cancer. Thick blood can sometimes cause blood clots to form in the heart, which can then travel to the brain and cause stroke. This study is being done to help figure out why this and other causes of stroke occur in people with cancer. The investigators expect that information from this study will help doctors to more effectively prevent and treat stroke in individuals with cancer.

This will be a prospective cross-sectional study to examine the unique mechanisms of ischemic stroke in cancer patients. Enrollment will occur at the NewYork-Presbyterian Hospital (NYPH)/Weill Cornell Medical Center (WCMC) and the Memorial Sloan Kettering Cancer Center (MSKCC). Measurements will occur at the NYPH/WCMC and MSKCC Neurovascular Ultrasound Laboratories, the MSKCC Central Laboratory, and the Sharp Laboratory at the University of California, Davis. Three groups of adult patients will be enrolled. Group 1 will consist of consecutive patients with active solid tumor cancer and acute ischemic stroke. Group 2 will be patients with acute ischemic stroke and no cancer. Patients in Groups 1 and 2 will be enrolled at 96 hours +/- 24 hours of stroke onset. Group 3 will include patients with active solid tumor cancer and no stroke. This group will allow us to confirm that differences between stroke patients with and without cancer are not simply incidental findings that can be expected in all cancer patients regardless of thrombotic status. Demographics, comorbidities, and stroke severity (for Groups 1 and 2 only) will be recorded on admission using a structured form. Study patients will undergo three facets of testing: 1) Transcranial Doppler (TCD) microemboli detection; 2) hematological biomarker testing; 3) peripheral blood leukocyte RNA gene expression analysis.

Mechanisms of Ischemic Stroke in Cancer Patients

With TCD studies, both middle cerebral arteries will be insonated for 30 minutes using a fixed headset. An experienced technologist will review the recording to ensure accurate characterization of all signals and a vascular neurologist with expertise in neurosonology will determine the rate and laterality of the microemboli. TCD microemboli in bilateral vascular distributions indicates a central embolic source.

Hematological testing will consist of a single peripheral blood draw at 96 hours (+/-24 hours). Several factors will be evaluated, including markers of coagulation (thrombin-antithrombin complex, D-dimer), platelet function (P-selectin), and endothelial integrity (sICAM-1, sVCAM-1, thrombomodulin).

Blood specimens will be collected at the time of enrollment in PAXgene tubes which will be frozen and stored at the Weill Cornell CTSC Core laboratory and sent in batches to the UC Davis laboratory where processing of RNA gene expression will occur.

University of California, Davis

Memorial Sloan Kettering Cancer Center

National Institute of Neurological Disorders and Stroke (NINDS)

Weill Medical College of Cornell University

Neoplasms

Brain Neoplasms

Infratentorial Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients with posterior fossa tumor scheduled for elective surgery will be enrolled in the study.

Transcranial Doppler will be used to assess the cerebral autoregulation and carbon dioxide reactivity of patients with posterior fossa tumor

Monitoring

Hemanshu Prabhakat, MD

Hemanshu Prabhakar, MD

The normal cerebral blood flow is guided by factors such as cerebral autoregulation (CA) and carbon dioxide reactivity (CO2R). Authors have demonstrated that CA and CO2R may be impaired in presence of intracranial tumors.Most studies pertaining to assessment of CA and CO2R in patients with brain tumors is limited to supratentorial tumors. Due to their anatomic location, posterior fossa tumors result in obstruction of ventricular outflow, produce hydrocephalus and features of raise intracranial pressure (ICP). It is possible that lesions in the posterior fossa may affect CA and CO2R. It should also be noted that posterior fossa surgeries are carried out in positions such as prone, lateral and sitting. Altered surgical positions themselves affect systemic hemodynamics which may influence cerebral blood flow; with presence of anesthetics further compromising the blood flow to the brain. Understanding the homeostatic mechanisms of CA and CO2R may help in deciding proper positioning of patients and maintenance of intraoperative hemodynamic.

The aim of this observational study was to evaluate CA and CO2R in patients with posterior fossa tumor prior to surgical decompression of the lesion.

Cerebral Blood Circulation in Patients With Posterior Fossa Brain Tumor

Cerebral Autoregulation and Carbon Dioxide Reactivity in Patients With Posterior Fossa Tumor

All India Institute of Medical Sciences, New Delhi

Hyperemia

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Anesthetics

Fentanyl

Isoflurane

Vecuronium Bromide

Patients undergoing craniotomy who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.

Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.

Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler (TCD) measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.

A 2-MHz Transcranial Doppler probe (MULTI-DOP P2.2C; DWL, Elektronische Systeme GmbH, Germany) will be used to measure both sides of Vmca of both patients undergoing craniotomy and patients undergoing abdominal surgery. The signal will be range-gated to a depth of 45 to 60 mm at temporal bone window to achieve the optimal signal according to standard techniques. The measures will be recorded in the operation room before anesthesia, in the recovery room at extubation, 30, 60, 90, and 120 min after extubation.

Transcranial Doppler (TCD)

After local anesthesia, a jugular venous bulb catheter(16G, manufactured by Arrow International Inc. USA) will be placed in the dominant side. The proper placement of the tip of the catheter in the jugular bulb will be confirmed later by a postoperative lateral skull X-ray. SjvO2 (blood sample will be drawn slowly at a speed of 2ml per minute) will be measured before anesthesia, at extubation, 30, 60, 90, and 120 min after extubation.

jugular venous bulb catheterization

Surgery types include total or subtotal removal of tumors.For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1\~2 µg/kg IV), and continuous vecuronium 50～70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.

Tumor removal surgery under general anesthesia

After local anesthesia, an intra-arterial pressure line(I.V. catheter and pressure line kit are both manufactured by Smiths Medical International Ltd. USA) will be inserted in radial artery. Sample blood will be drawn from the line before anesthesia, at tracheal extubation, and 30, 60, 90, 120 min after tracheal extubation.

Radial artery catheterization

For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1\~2 µg/kg IV), and continuous vecuronium 50～70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.

Abdominal surgery under general anesthesia

Xiao-Yu Yang, Master

Shou-Jing Zhou, Master

Few studies look into cerebral blood flow (CBF) changes during emergence from general anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation of jugular vein bulb and transcranial Doppler.

30 patients undergoing selective craniotomy (craniotomy group) for supratentorial brain tumor removal and 30 patients undergoing selective abdominal surgery (abdominal surgery group) are planned to be enrolled in the study. Mean blood flow velocity in middle cerebral artery (Vmca), mean arterial pressure (MAP), blood oxygen saturation of jugular vein bulb (SjvO2) (only measured in craniotomy group)and arterial CO2 partial pressure (PaCO2) will be measured before general anesthesia, at tracheal extubation, and 30,60, 90, 120 min after extubation in both groups.

Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

Cerebral Hyperemia During Emergence From General Anesthesia for Craniotomy of Patients With Brain Tumor

It was the baseline mean blood flow velocity in middle cerebral artery.

Huashan Hospital

Principal Investigator

Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.

Abdominal Surgery Group

Randomly chosen patients undergoing selective craniotomy surgery. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and craniotomy under general anesthesia will be performed.

Craniotomy Group

Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.

Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.

Total

Age, Categorical

Age Continuous

Sex: Female, Male

China

Region of Enrollment

Duration of Surgery

The study population was not homogenous according to tumor size and location.

Xiao-Yu Yang

H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.

Power calculation: beta=0.2, alpha=0.05, two-tailed

The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.

Mean Blood Flow Velocity in Middle Cerebral Artery

H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.

Power calculation: beta=0.2, alpha=0.05, two-tailed

H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.

Power calculation: beta=0.2, alpha=0.05, two-tailed

H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.

Power calculation: beta=0.2, alpha=0.05, two-tailed

H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.

Power calculation: beta=0.2, alpha=0.05, two-tailed

H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.

Power calculation: beta=0.2, alpha=0.05, two-tailed

Oxygen Saturation of Jugular Venous Bulb

Overall Study

Wounds and Injuries

Hemorrhage

Subarachnoid Hemorrhage

Cerebral Hemorrhage

Hydrocephalus

Craniocerebral Trauma

Intracranial Hemorrhages

Trauma, Nervous System

Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or hydrocephalus.

Yi-Hsin Tsai, M.D.

The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.

Transcranial Doppler (TCD) and Transcranial color-coded duplex sonography (TCCS) play an important part in neurocritical monitoring systems. Currently there are studies using flow velocities and pulsatility index (PI) to predict intracranial pressure (ICP) and clinical outcome. But the use of B-mode in such prediction is not yet investigated. The purposes of this study are to establish the correlation among clinical data, CT findings and information collected by TCCS, and to predict ICP and neurological outcome using such information. The focus would be on 3rd ventricle size, midline shift and anteroposterior-transverse ration of midbrain (midbrain index) obtained by B-mode of TCCS. This study is a prospective clinical study targeting on 30 neurocritical patients admitted to intensive care units in one year. The timing of performance of TCCS will be (1) within 6 hours after admission, (2) within 6 hours after each CT examination, and (3) when ICP is higher than 20 mmHg for more than 5 minutes. Glasgow coma scale (GCS), heart rate, blood pressure (systolic, diastolic, and mean), body temperature, central venous pressure (CVP), brain temperature, ICP, cerebral perfusion pressure (CPP), mean velocity (MV) of bilateral middle cerebral arteries (MCAs), PI, midline shift, 3rd ventricular dimension, anteroposterior to transverse ratio of midbrain (midbrain index, MI) are recorded. The latter three parameters are also obtained from CT scans, and compared with those obtained from TCCS. Outcome is evaluated with extended Glasgow outcome scale (GOSE), and analyzed with previous records. This study is going to prove that TCCS is a safe, convenient, real-time and cheap tool in clinical care for neurocritical patients. It also provides prediction of ICP and clinical outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mechanisms of Ischemic Stroke in Cancer Patients	NCT02604667	Stroke Cancer	Blood tests Transcranial Do...	18 Years -	Weill Medical College of Cornell University
Cerebral Blood Circulation in Patients With Posterior Fossa Brain Tumor	NCT01476670	Brain Tumor	Monitoring	18 Years - 60 Years	All India Institute of Medical Sciences, New Delhi
Mechanisms of Ischemic Stroke in Cancer Patients	NCT02604667	Stroke Cancer	Blood tests Transcranial Do...	18 Years -	Weill Medical College of Cornell University
Cerebral Blood Circulation in Patients With Posterior Fossa Brain Tumor	NCT01476670	Brain Tumor	Monitoring	18 Years - 60 Years	All India Institute of Medical Sciences, New Delhi
Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy	NCT01642147	Brain Neoplasms Surgery Hyperemia	Transcranial Do... jugular venous ... Tumor removal s... Radial artery c... Abdominal surge...	25 Years - 60 Years	Huashan Hospital
Mechanisms of Ischemic Stroke in Cancer Patients	NCT02604667	Stroke Cancer	Blood tests Transcranial Do...	18 Years -	Weill Medical College of Cornell University
The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients	NCT00886054	Head Injury Intracerebral H... Ischemic Stroke Subarachnoid He... Brain Tumor Hydrocephalus		16 Years - 80 Years	National Taiwan University Hospital

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