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NCT ID: NCT00994903 Completed - Perioperative Care Clinical Trials

Simvastatin in Colorectal Surgery

StatCol
Start date: October 2011
Phase: Phase 3
Study type: Interventional

Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs that have an established role in the medical management of cardiovascular disease. Their benefits have also been shown in the surgical setting with decreased cardiovascular complications and lower perioperative mortality following cardiac and vascular surgery. There is now considerable evidence showing statins have useful pleiotropic properties that extend beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating the proinflammatory and metabolic stress response to surgery and the benefit of statins may extend to other surgical settings such as abdominal surgery. Laboratory studies demonstrate the surgically-relevant benefits of statins and show they decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion injury, improve survival in models of abdominal sepsis, decrease the formation of postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses. Retrospective clinical studies show statins improve outcomes in sepsis, reduce the postoperative systemic inflammatory response syndrome (SIRS) and are associated with decreased rates of surgical wound infections and postoperative respiratory complications following various non-cardiac general surgical procedures. However, no prospective studies have specifically evaluated the perioperative use of statins in abdominal surgery. Using colorectal surgery as a model for major abdominal surgery, the investigators will conduct a randomised controlled trial evaluating the effect of perioperative statin use on postoperative morbidity, local and systemic inflammatory response, and functional recovery after surgery.

NCT ID: NCT00987688 Completed - Clinical trials for Brain Injuries, Traumatic

The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury

POLAR-RCT
Start date: April 2010
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is a leading cause of death and long term disability, particularly in young adults. Studies from Australia have shown that approximately half of those with severe traumatic brain injury will be severely disabled or dead 6 months post injury. Given the young age of many patients with severe TBI and the long term prevalence of major disability, the economic and more importantly the social cost to the community is very high. Pre-hospital and hospital management of patients with severe brain injury focuses on prevention of additional injury due primarily to lack of oxygen and insufficient blood pressure. This includes optimising sedation and ventilation, maintaining the fluid balance and draining Cerebrospinal Fluid (CSF) and performing surgery where appropriate. In recent years there has been a research focus on specific pharmacologic interventions, however, to date, there has been no treatment that has been associated with improvement of neurological outcomes. One treatment that shows promise is the application of hypothermia (cooling). This treatment is commonly used in Australia to decrease brain injury in patients with brain injury following out-of-hospital cardiac arrest. Cooling is thought to protect the brain using a number of mechanisms. There have been a number of animal studies that have looked at how cooling is protective and also some clinical research that suggests some benefit. However at the current time there is insufficient evidence to provide enough proof that cooling should be used routinely for patients with brain injury and like all treatments there can be some risks and side effects. The POLAR trial has been developed to investigate whether early cooling of patients with severe traumatic brain injury is associated with better outcomes. It is a randomised controlled trial, which is a type of trial that provides the highest quality of evidence. The null hypothesis is that there is no difference in the proportion of favourable neurological outcomes six months after severe traumatic brain injury in patients treated with early and sustained hypothermia, compared to standard normothermic management.

NCT ID: NCT00987454 Completed - Clinical trials for Traumatic Brain Injury

Erythropoietin in Traumatic Brain Injury (EPO-TBI)

EPO-TBI
Start date: May 2010
Phase: Phase 3
Study type: Interventional

This study seeks to determine if erythropoietin alpha (EPO) administered to adult critical care patients with moderate or severe traumatic brain injury improves neurological function assessed at six months after injury.

NCT ID: NCT00987389 Completed - Clinical trials for Microscopic Polyangiitis (MPA)

Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis

PEXIVAS
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen. The FDA-OOPD is one of the funding sources for this study.

NCT ID: NCT00986154 Completed - Clinical trials for Venous Thromboembolism

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

NCT ID: NCT00980330 Completed - Hepatitis C Clinical Trials

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

ASPIRE
Start date: October 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

NCT ID: NCT00977938 Completed - Clinical trials for Coronary Artery Disease

The Dual Antiplatelet Therapy Study (DAPT Study)

Start date: October 2009
Phase: Phase 4
Study type: Interventional

The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

NCT ID: NCT00977925 Completed - Clinical trials for Soft Tissue Bleeding

The Severe Soft Tissue Bleeding Study

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.

NCT ID: NCT00975195 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

Start date: February 2009
Phase: Phase 4
Study type: Interventional

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

NCT ID: NCT00974350 Completed - Surgery Clinical Trials

A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

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

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia. The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.