Trials
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Randomized Controlled Trial Multicenter Study
Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: statistical analysis plan.
Venous thromboembolism (VTE) is a common and important complication of stroke. The CLOTS 3 trial aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression (IPC) in immobile stroke patients reduces the risk of proximal deep vein thrombosis (DVT). ⋯ The CLOTS 3 trial is a multicenter, parallel group trial with centralized randomization (minimization) to ensure allocation concealment. The protocol has been published (Trials 2012, 13:26) and is available in full at: http://www.clotstrial.com. Between December 2008 and September 2012, 105 centers in the UK recruited 2,876 immobile stroke patients within the first 3 days of their hospital admission. Patients were allocated to best medical care or best medical care plus IPC. Ultrasonographers performed a compression Doppler ultrasound scan to detect DVT in each treatment group at 7 to 10 days and 25 to 30 days. The primary outcome cluster includes symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either scan. Patients will be followed up by postal or telephone questionnaire at 6 months from randomization to detect later symptomatic DVT and pulmonary embolism (PE), and to measure functional outcome (Oxford Handicap Scale) and quality of life (EQ-5D-3L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has more than 90% power to detect a 4% absolute difference (12% versus 8%) in risk of the primary outcome and includes a health economic analysis.Follow-up will be completed in April 2013 and the results reported in May 2013. In this update, we describe the statistical analysis plan.
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Randomized Controlled Trial Comparative Study
Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial.
Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual'). ⋯ A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care.
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Randomized Controlled Trial
Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial.
Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain. ⋯ The results from this study will provide clinical evidence on the efficacy and safety of bee venom acupuncture in patients with chronic non-specific low back pain.
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Randomized Controlled Trial
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial.
Anaemia following hip fracture is common. Approximately 30 to 45% of patients have haemoglobin concentrations below population norms on admission, and around 10% are severely anaemic. Anaemia on admission, and in the postoperative period, is associated with poor outcomes with regard to mobility, postoperative mortality and readmission. There is currently no clear consensus on the optimal method of managing perioperative anaemia in this group of frail patients with frequent comorbidity. Liberal red cell transfusion in the postoperative period does not appear to improve outcome, whereas tranexamic acid appears to reduce transfusion rate at the expense of increased cardiovascular morbidity. There are encouraging results from one centre with the use of agents to stimulate red cell production, including intravenous iron and erythropoietin. UK practice differs significantly from these patients and these studies, and it is not clear whether these promising results will translate to the UK population. ⋯ This is a pilot study to demonstrate haematopoietic efficacy of intravenous iron in this setting. Hence, we have chosen to measure change in reticulocyte count rather than the more clinically relevant differences in haemoglobin concentration or transfusion rate. If our results are positive, the study will provide the necessary information for development of a full-scale trial of intravenous iron.
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Randomized Controlled Trial
Intermittent preventive treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine regimens in schoolchildren of the Democratic Republic of Congo: a study protocol for a randomized controlled trial.
In malaria endemic areas, schoolchildren usually have asymptomatic malaria infections and consequently remain untreated. Therefore, intermittent preventive treatment with sulfadoxine-pyrimethamine in schoolchildren would be a plausible strategy in malaria stable transmission areas to prevent anaemia and malnutrition. However, in contrast to infancy and pregnancy, antimalaria intermittent preventive treatment in children has been barely investigated. As the implementation of intermittent preventive treatment may be challenged by sulfadoxine-pyrimethamine resistance, sulfadoxine-pyrimethamine combined with piperaquine may be a better alternative than sulfadoxine-pyrimethamine monotherapy. A clinical trial is being conducted to assess the efficacy and safety of intermittent preventive treatments versus controls in Democratic Republic of Congo (DRCongo) schoolchildren and their impact on sulfadoxine-pyrimethamine resistance. ⋯ The very few studies on intermittent preventive treatment in schoolchildren in malaria stable transmission areas have contradictory results. This randomised controlled trial is unique in comparing efficacy and safety of a prophylactic combination therapy to monotherapy or a control group after 12 months follow-up. Resistance markers for sulfadoxine-pyrimethamine (including break through parasitaemias) will also be recorded. Its uniqueness lies also in the fact that we use piperaquine, a long acting antimalarial, in combination with sulfadoxine-pyrimethamine. Artemisinin derivatives have been excluded as it is part of the treatment policies in virtually all malaria endemic countries. Our findings may, therefore, contribute to the public health of youngsters who fail to thrive and grow due to multiple morbidities.