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Cerebral Hemorrhage clinical trials

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NCT ID: NCT00598572 Completed - Clinical trials for Intracerebral Hemorrhage

Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage

DFO In ICH
Start date: July 2008
Phase: Phase 1
Study type: Interventional

Animal studies show that the breakdown of blood results in iron accumulation in the brain after brain hemorrhage (ICH); and that iron plays a role in brain injury in ICH patients. Deferoxamine (DFO) has been extensively used in clinical practice for more than 30 years to remove excessive iron from the body, and has been shown to provide some benefit in animal studies of ICH. Therefore, we plan to undertake this study to evaluate the safety and tolerability of treatment with DFO in patients with ICH, and to determine the maximal tolerated dose to be used in future studies to determine if treatment with DFO can improve the outcome of patients with ICH. Our main objectives are: 1) to evaluate the safety and tolerability of varying doses of DFO, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the maximal tolerated dose to be adopted in subsequent studies to test the efficacy of DFO in improving outcome after ICH. We hypothesize that DFO is well-tolerated and has minimal serious adverse effects in patients with ICH; and that treatment with DFO will improve patients' outcome. The results can potentially bring into account new means to improve the outcome of patients with ICH. ICH is a frequent cause of disability and death. A successful study demonstrating the efficacy of iron-modifying therapy would be of considerable public health significance.

NCT ID: NCT00589953 Terminated - Brain Injury Clinical Trials

High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years suggest in both animal and human studies that erythropoietin (Epo) may have significant neuroprotective effects. Given the historical safe medical profile of Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase II study of high-dose Epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.

NCT ID: NCT00579943 Completed - Clinical trials for Infant, Premature, Diseases

Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants

Start date: May 2001
Phase: N/A
Study type: Observational

Advances in newborn intensive care have lead to dramatic improvements in survival for the most premature infants—often weighing 1 pound at birth. Unfortunately, cerebral palsy, mental retardation, and developmental delay affect more than 10,000 of these premature infants in the U.S. annually. In his studies, Dr. Jeffrey R. Kaiser is trying to understand why these premature infants are at such high risk of brain injury, and to learn ways to prevent injury. Experts believe that disturbances of brain blood flow regulation are important in causing these injuries. Using a novel continuous monitoring system, Dr. Kaiser is able to determine an infant's capacity for normal brain blood flow regulation. Contrary to previous thinking, he has shown that many of these babies in fact due have normal regulation of their brain blood flow. He has observed that brain blood flow may be disturbed during suctioning of the breathing tube. Further, he has also shown that infants with high carbon dioxide, those not breathing well, have impaired regulation of their brain blood flow. Thus, even stable infants are prone to disturbed brain regulation during routine intensive care, which may lead to bleeding in the brain and long-term neurologic problems. Dr. Kaiser will study up to 200 infants to determine 1) the developmental pattern of normal regulation of cerebral blood flow; 2) in those with impaired regulation, determine when it develops during the first week of life; and 3) determine the relationship between impaired brain blood flow regulation and brain injury. Results from this study will help us recognize when premature infants are most vulnerable to developing brain injury, allowing prevention and intervention strategies to be initiated in a timely fashion.

NCT ID: NCT00566709 Completed - Clinical trials for Traumatic Brain Injury

Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients

Start date: June 2009
Phase: Phase 2
Study type: Interventional

Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in these patients has been associated with deleterious effects, including higher rates of nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to avoid any unnecessary RBCT. Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies including neurocritical patients suggested that severe anemia may worsen clinical outcome. Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown. Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin levels near to 10 g/dL, despite the lack of a solid scientific background supporting this target. Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested that more physiological transfusion triggers, using direct signals coming from the brain, will progressively replace arbitrary hemoglobin-based transfusion triggers in the neurocritical patients [65]. At the neurocritical units, patients are often monitored by using non-invasive methods, such as near infrared spectroscopy which indirectly measures regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome and other variables which are often monitored in TBI patients. The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care unit.

NCT ID: NCT00526214 Completed - Clinical trials for Intracerebral Hemorrhage

Administration of Celecoxib for Treatment of Intracerebral Hemorrhage : A Pilot Study

ACE-ICH
Start date: October 2007
Phase: N/A
Study type: Interventional

Primary: Change of volume of perihematomal edema as assessed by brain CT. Secondary: The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study

NCT ID: NCT00490464 Completed - Clinical trials for Subarachnoid Hemorrhage

Safety and Efficacy of Nicardipine for the Control of Blood Pressure After SAH

Start date: June 2004
Phase: N/A
Study type: Observational

The purpose of this research is to explore ways to improve and simplify control of blood pressure in patients with SAH or ICH. This research will be done by comparing tow different medications that are routinely used to help control blood pressure. None of the medications used in this study nor any procedures performed are experimental.

NCT ID: NCT00426803 Completed - Clinical trials for Acquired Bleeding Disorder

Recombinant Factor VIIa in Acute Intracerebral Haemorrhage

Start date: August 2002
Phase: Phase 2
Study type: Interventional

This trial is conducted in North America, Europe, Asia and Oceania. The purpose of this study is to evaluate safety and efficacy of Recombinant Factor VIIa in patients with acute intracerebral bleeding.

NCT ID: NCT00419874 Recruiting - Clinical trials for Traumatic Brain Injury

Characteristics of Blood- Brain Barrier Permeability in Neurological Patients

Start date: n/a
Phase: N/A
Study type: Observational

The main goal of the present study is to challenge the hypothesis that blood- brain barrier disruption following brain injury increases the risk for long-term disability, development of brain dysfunction, epileptic seizures and neuroanatomical alterations.

NCT ID: NCT00418353 Completed - Clinical trials for Respiratory Distress Syndrome

Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"

Start date: August 2002
Phase: N/A
Study type: Interventional

Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. No human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.

NCT ID: NCT00415610 Completed - Stroke Clinical Trials

Antihypertensive Treatment in Acute Cerebral Hemorrhage

ATACH
Start date: July 2005
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to evaluate the safety and effectiveness of lowering blood pressure using nicardipine in persons with acute hypertension associated with intracerebral hemorrhage.