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Brain Ischemia clinical trials

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NCT ID: NCT02351518 Completed - Cerebral Ischemia Clinical Trials

Cerebral Autoregulation and Vasospasm in Patients With TBI

Start date: November 2015
Phase:
Study type: Observational

Traumatic brain injury (TBI) affects 1.5 million patients per year in the United States, resulting in more than 50,000 deaths and more than 230,000 hospitalizations annually. Approximately 90,000 of these patients will suffer permanent impairment and more than half will experience short-term disability. Secondary injury processes play a critical role in the development of ischemia after trauma to the central nervous system and occur hours-to-days after the primary insult. Ischemia can lead to cerebral infarction or stroke. Ischemia has been described as the single most important secondary insult and has been identified histologically in approximately 90% of patients who die following closed head injury. Several factors resulting in post-traumatic cerebral ischemia have been identified: increased intracranial pressure (ICP), systemic arterial hypotension, and cerebral vasospasm. Cerebral vasospasm has been described as a sustained arterial narrowing. Clinically, the onset of new or worsening neurological symptoms is the most reliable indicator of cerebral vasospasm following a ruptured cerebral aneurysm. However, cerebral vasospasm is often unrecognized in patients suffering from moderate to severe TBI. These patients frequently have altered mental status due to the primary brain injury. In addition, they require narcotics for their pain and paralytics and/or sedatives while on a mechanical ventilator for airway protection. Thus, relying on the neurological exam to observe deteriorating neurological signs consistent with post-traumatic vasospasm (PTV) is reliable. While the etiology and outcome of patients with vasospasm secondary to ruptured aneurysm is well documented, the clinical significance of PTV after TBI is unknown. A better understanding of the role of cerebral autoregulation in the development of cerebral vasospasm could provide the answer. This proposal is for a pilot observational study describing the association of the impairment of cerebral autoregulation as measured by near infrared spectroscopy (NIRS) with the development of clinically significant vasospasm in patients with moderate to severe TBI. The information will serve as preliminary data for further study.

NCT ID: NCT02349672 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)

Start date: March 2016
Phase:
Study type: Observational

Hypoxic-ischemic encephalopathy (HIE) is a serious birth complication due to systemic asphyxia which occurs in about 20 of 1,000 full-term infants and nearly 60% of premature newborns. Between 10-60% of babies who exhibit HIE die during the newborn period and up to 25% of the HIE survivors have permanent neurodevelopmental handicaps in the form of cerebral palsy, mental retardation, learning disabilities, or epilepsy. HIE also has a significant financial impact on the health care system. In the state of Florida, the total cost for initial hospitalization is $161,000 per HIE patient admitted, but those costs don't take into account the life-long costs. Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia treatment rely on a combination of a neurological exam, ultrasound, magnetic resonance imaging (MRI) and electroencephalography (EEG). However, these methods do a poor job in identifying non-responders to hypothermia. MRI requires transport of the neonate with a requisite 40-45 min scan, which is not appropriate for unstable neonates. Moreover, the amplitude integrated EEG (aEEG), a common bedside monitoring technique currently used in these patients to assess candidates and predict outcomes prior to hypothermia, can be adversely affected by hypothermia itself and the patient may not appear to improve until re-warming. Consequently, the development of a simple, inexpensive, non-invasive, rapid biochemical test is essential to identify candidates for therapeutic hypothermia, to distinguish responders from non-responders and to assess outcome. This research is the first step needed to treat neonates with HIE employing a personalized medical approach using serum proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic hypothermia. These biomarkers will aid in the direct care by providing a rapid test to predict outcomes and select candidates who are likely to benefit from therapeutic hypothermia and gauge a response to the neuroprotective intervention.

NCT ID: NCT02323685 Completed - Cerebral Ischemia Clinical Trials

Safety and Effect of SANGUINATEā„¢ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)

Start date: December 2014
Phase: Phase 2
Study type: Interventional

Safety and effect of SANGUINATE on patients DCI following SAH.

NCT ID: NCT02315443 Completed - Clinical trials for Acute Cerebral Ischemia

Field Randomization of Nerinetide (NA-1) Therapy in Early Responders

FRONTIER
Start date: March 26, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether nerinetide (NA-1) is effective in reducing global disability in patients with acute cerebral ischemia if administered early after symptom onset.

NCT ID: NCT02310191 Completed - Carotid Stenosis Clinical Trials

Correlation Between Laboratory Markers and Origin of New Brain Ischemic Lesions After Carotid Stenting

Start date: July 2012
Phase: N/A
Study type: Observational

New brain ischemic lesions are detected in about 50% of patients undergoing carotid artery stenting (CAS). The aim was to assess correlation between selected laboratory markers and occurrence of new brain infarctions after CAS.

NCT ID: NCT02287077 Completed - Clinical trials for Hypoxic Ischemic Encephalopathy

Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Start date: December 2014
Phase: N/A
Study type: Interventional

The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.

NCT ID: NCT02264808 Completed - Clinical trials for Hypoxic-Ischemic Encephalopathy

Developmental Outcomes

Start date: November 2014
Phase:
Study type: Observational

Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.

NCT ID: NCT02260271 Enrolling by invitation - Clinical trials for Hypoxic-Ischemic Encephalopathy

Florida Neonatal Neurologic Network

FN3
Start date: September 2011
Phase:
Study type: Observational

Create a database with selected medical information on infants born with hypoxic-ischemic encephalopathy (HIE). In addition, the following samples will be collected in a bio-repository for future studies: blood, urine, and buccal samples.

NCT ID: NCT02256618 Completed - Clinical trials for Hypoxic-ischemic Encephalopathy

Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

Start date: August 2014
Phase: Phase 1
Study type: Interventional

This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

NCT ID: NCT02252848 Recruiting - Clinical trials for Hypoxic Ischemic Encephalopathy (HIE)

Phase I Clinical Trial to Determine the Safety of Clonidine in Infants With HIE During Therapeutic Hypothermia.

Start date: March 2014
Phase: Phase 1
Study type: Interventional

Hypoxic ischemic encephalopathy (HIE) occurs in ~ 2-4/1000 term infants and is a major cause of neonatal morbidity and mortality. To date, therapeutic hypothermia started within 6 h of birth is the only intervention known to be effective in reducing the morbidity and mortality of HIE. Hypothermia does not totally reverse the injury in many infants and is associated with side effects that may compromise its effectiveness. Low dose morphine is often used to reduce shivering in infants undergoing therapeutic hypothermia, but escalating doses of sedatives/analgesics are often required. Escalating doses of opioids and benzodiazepines causes respiratory depression and can either cause the need for or prolong mechanical ventilation.Agonists to the central a2 - adrenergic receptors are more effective at reducing postoperative shivering than opioid receptor agonists and provide analgesia and sedation without respiratory depression. The most desirable sedative-analgesic agent used in infants with HIE would: (a) have an excellent safety profile, (b) reduce shivering, (c) provide adequate analgesia and sedation, (d) cause minimal respiratory depression, (e) preserve cerebrovascular autoregulation, and (f) confer neuroprotection.