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Hemorrhage clinical trials

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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: NCT00562445 Recruiting - Acute Pancreatitis Clinical Trials

Adrenal Insufficiency in Critical Emergencies in Digestive Diseases

Start date: May 2007
Phase: N/A
Study type: Observational

Observational study about the incidence of relative adrenal insufficiency in patients with cirrhosis and acute variceal bleeding; in patients with acute peptic gastrointestinal bleeding and without liver disease; and in patients with severe acute pancreatitis. This is a study using pharmaceutical specialties in the approved conditions of use.

NCT ID: NCT00558311 Completed - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping

CONSCIOUS-2
Start date: December 14, 2007
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within 6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following: 1. Death (all causes). 2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 4. Neurological signs or symptoms (depending on state of consciousness), in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration of a valid rescue therapy. An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

NCT ID: NCT00549159 Recruiting - Clinical trials for Dysfunctional Uterine Bleeding

CavatermTM vs TCRE in Women With DUB

Start date: October 2007
Phase: Phase 4
Study type: Interventional

The purpose of study is to compare the treatment success in the study groups.

NCT ID: NCT00546169 Completed - Hemorrhage Clinical Trials

Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

Start date: June 2007
Phase: N/A
Study type: Observational

- Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute) - Evaluation of TachoSil in laparoscopic cholecystectomy - Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy - Pharmaco-economic evaluation - Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures. Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.

NCT ID: NCT00538538 Withdrawn - Clinical trials for Macular Degeneration

Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)

Start date: September 2007
Phase: Phase 1
Study type: Interventional

Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed that no statistically significant improvement in vision resulted from surgical removal of the layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into the gel of the eye along with removal of the blood has shown some success. However, this does not treat the underlying condition of the AMD. Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to be highly effective in the treatment of AMD, yet its penetration through areas of thick blood caused by subretinal hemorrhage is not known. This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed by Lucentis placed between the layers of the retina and then with or without a gas bubble. In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not.

NCT ID: NCT00526500 Recruiting - Clinical trials for Traumatic Brain Injury

Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.

Start date: August 2006
Phase: Phase 0
Study type: Interventional

The aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials). Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury. 2) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.

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: NCT00519519 Completed - Clinical trials for Bleeding Peptic Ulcers Disease

Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

Start date: July 2004
Phase: Phase 3
Study type: Interventional

Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital emergency admissions.The initial treatment is endoscopic therapy followed by intravenous omeprazole. However the optimal dosage of omeprazole is not known. We conducted this study to find out the optimal dosage in such clinical scenario.

NCT ID: NCT00515736 Terminated - Trauma Clinical Trials

Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome

Etude-AOX
Start date: January 2003
Phase: Phase 3
Study type: Interventional

Critically ill patients are generally exposed to an increased oxidative stress, which is proportional to the severity of their condition. Endogenous antioxidant (AOX) defenses are depleted particularly in those patients with intense inflammatory response. The hypothesis tested is that early I:V: administration of a combination of AOX micronutrient supplements (Se, Zn, Vit C, Vit E, Vit B1) would improve clinical outcome in selected critically ill patients, by reinforcing the endogenous AOX defenses and reducing organ failure.