Clinical Trial News

Effect of Steroids, Controlling Blood Sugar Levels, and Avoidance of Deep Anesthesia on Patient Outcomes After Major Vascular Surgery is a randomized, double-blind, placebo-control, parallel-assignment study to determine whether outcomes following peripheral vascular surgery or open abdominal aortic aneurysm repair can be positively influenced by the use of dexamethasone, intensive glucose management, and lighter anesthetic management, compared with placebo, conventional practice of glucose management, and deeper anesthetic. The study is currently recruiting, and patients must be aged 50 years or older, scheduled for peripheral vascular surgery or open AAA repair, and must not have had an isolated carotid endarterectomy or recent steroid therapy. The primary outcomes are the incidence and rate of major perioperative morbidity. Secondary outcomes include a reduction of circulating concentrations of the inflammatory marker C-reactive protein, incidence and rate of minor surgical complications, postoperative nausea and vomiting, postoperative delirium, time to hospital discharge, postoperative quality of life, and all-cause 1-year mortality. The study is being sponsored by the Cleveland Clinic. It began in February 2007, and has a total expected enrollment of 984 patients. The ClinicalTrials.gov identifier is NCT00433251.

Autologous Bone Marrow Transplantation for Critical, Limb-Threatening Ischemia is a phase II randomized, double-blind, placebo-control, parallel-assignment safety/efficacy study to determine if a transplantation of a patient's own concentrated bone marrow cells can positively affect outcomes in patients with peripheral arterial occlusive disease, diabetic foot, leg ulcers, gangrene, or ischemia. The theory behind the study is that bone marrow cell concentrate will stimulate angiogenesis through augmented formation of collateral vessels in the ischemic limb, leading to therapeutic improvement. Primary outcomes are major amputation of the index limb and persisting critical limb-threatening ischemia. Secondary outcomes include wound healing (wound size and stage), pain and analgesics use, Rutherford grade and stage, walking distance (treadmill) if possible, quality of life based on the EQ-5D questionnaire, transcutaneous oxygen pressure, ankle brachial index, rate and extent of minor (below the ankle) amputations, and perioperative cardiovascular morbidity and mortality. The study is sponsored by Franziskus-Krankenhaus and the Berlin Vascular Center and is scheduled to begin in March 2007, with a total expected enrollment of 90 patients and an expected completion date of January 2009. The ClinicalTrials.gov identifier is NCT00434616.