Division of Clinical neurosciences, University of Edinburgh Western General Hospital, Edinburgh EH4 2XU, UK.
Trials. 2012 Mar 8;13:26. doi: 10.1186/1745-6215-13-26.
Approximately 80,000 patients each year are admitted to U.K. hospitals with an acute stroke and are immobile. At least 10% will develop a proximal deep vein thrombosis in the first month and 1.5% a pulmonary embolus. Although hydration, antiplatelet treatment and early mobilisation may reduce the risk of deep vein thrombosis, there are currently no preventive strategies which have been clearly shown to be both effective and safe. Anticoagulation increases the risks of bleeding and compression stockings are ineffective. Systematic reviews of small randomized trials of intermittent pneumatic compression have shown that this reduces the risk of deep vein thrombosis in patients undergoing surgery, but that there are few data concerning its use after stroke. The CLOTS trial 3 aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression in immobile stroke patients reduces the risk of proximal deep vein thrombosis.
METHODS/DESIGN: CLOTS Trial 3 is a parallel group multicentre trial; with centralized randomisation (minimisation) to ensure allocation concealment. Over 80 centres in the U.K. will recruit 2800 immobile stroke patients within the first 3 days of their hospital admission. Patients will be allocated to best medical care or best medical care plus intermittent pneumatic compression. Ultrasonographers will perform a Compression Duplex Ultrasound Scan to detect deep vein thrombosis in each treatment group at about 7-10 days and 25-30 days. The primary outcome cluster includes symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on either scan. Patients are then followed up by postal or telephone questionnaire at 6 months from randomisation to detect later symptomatic deep vein thrombosis and pulmonary emboli and to establish their functional outcome (Oxford handicap scale) and quality of life (EQ5D-3 L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has 90% power to detect a 4% absolute difference in risk of the primary outcome and includes a health economic analysis.
The trial started recruitment in Dec 2008 and will complete recruitment during 2012. It will report results in 2013.
ISRCTN: ISRCTN93529999.
每年约有 8 万名急性中风且无法活动的患者入住英国医院。其中至少有 10%的患者在第一个月内会发生近端深静脉血栓形成，1.5%的患者会发生肺栓塞。尽管补液、抗血小板治疗和早期活动可能会降低深静脉血栓形成的风险，但目前还没有明确有效的预防策略。抗凝治疗会增加出血风险，而压缩袜则无效。对间歇性气动压迫的小型随机试验的系统评价表明，这种方法可降低接受手术的患者发生深静脉血栓形成的风险，但关于其在中风后的应用的数据很少。CLOTS 试验 3 旨在确定与最佳医疗护理相比，在无法活动的中风患者中，最佳医疗护理加间歇性气动压迫是否可降低近端深静脉血栓形成的风险。
方法/设计：CLOTS 试验 3 是一项平行组多中心试验；采用集中随机化（最小化）以确保分配隐匿。英国 80 多个中心将在患者入院后 3 天内招募 2800 名无法活动的中风患者。患者将被分配到最佳医疗护理或最佳医疗护理加间歇性气动压迫。超声医师将在治疗组的大约第 7-10 天和第 25-30 天进行压缩双功能超声扫描以检测深静脉血栓形成。主要结局簇包括在任何一次扫描中检测到的腘静脉或股静脉的症状性或无症状性深静脉血栓形成。随后，患者在随机分组后 6 个月通过邮寄或电话问卷调查来检测迟发性症状性深静脉血栓形成和肺栓塞，并确定其功能结局（牛津残疾量表）和生活质量（EQ5D-3 L）。进行扫描的超声医师对治疗分配不知情，而患者和护理人员知情。该试验有 90%的把握度可检测出主要结局风险的 4%绝对差异，并包括卫生经济学分析。
该试验于 2008 年 12 月开始招募患者，预计将于 2012 年完成招募。研究结果将于 2013 年公布。
ISRCTN: ISRCTN93529999。
