Ottawa Stroke Program, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, School of Epidemiology, Public Health and Preventative Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
BMJ Open. 2018 Nov 5;8(11):e024405. doi: 10.1136/bmjopen-2018-024405.
Patients with an intracerebral haemorrhage are at increased risk of venous thromboembolism. Pharmacotherapy and pneumatic compression devices are capable of preventing venous thromboembolism, however both interventions have limitations. There are no head-to-head comparisons between these two interventions. To address this knowledge gap, we plan to perform a systematic review and network meta-analysis to examine the comparative effectiveness of pharmacological prophylaxis and mechanical compression devices in the context of intracerebral haemorrhage.
MEDLINE, PUBMED, EMBASE, CENTRAL, ClinicalTrials.gov and the Internet Stroke Trials Registry will be searched with assistance from an experienced information specialist. Eligible studies will include those that have enrolled adults presenting with spontaneous intracerebral haemorrhage and compared one or more of the respective interventions against each other and/or a control. Primary outcomes to be assessed are occurrence of new venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) and haematoma expansion, defined as a significant enlargement of baseline haemorrhage or new haemorrhage occurrence. Both randomised and non-randomised comparative studies will be included. Data on participant characteristics, study design, intervention details and outcomes will be extracted. Study quality will be assessed using the Cochrane Risk of Bias Tool and the Robins-I tool. Bayesian network meta-analyses will be performed to compare interventions based on all available direct and indirect evidence. If the transitivity assumption for network meta-analysis cannot be met, we will perform a qualitative assessment.
Formal ethics is not required as primary data will not be collected. The findings of this study will be disseminated through conference presentations, and peer-reviewed publications. In an area of clinical practice where equipoise exists, the findings of this study may assist in determining which treatment intervention is most effective in venous thromboembolism prevention.
CRD42018090960.
脑出血患者发生静脉血栓栓塞的风险增加。药物治疗和气动压缩装置能够预防静脉血栓栓塞，但这两种干预措施都存在局限性。目前尚无这两种干预措施的头对头比较。为了解决这一知识空白，我们计划进行系统评价和网络荟萃分析，以检查脑出血背景下药物预防和机械压缩装置的比较效果。
将在经验丰富的信息专家的协助下，检索 MEDLINE、PUBMED、EMBASE、CENTRAL、ClinicalTrials.gov 和互联网中风试验登记处。符合条件的研究将包括纳入患有自发性脑出血的成年患者的研究，并将一种或多种干预措施相互比较，以及与对照组进行比较。评估的主要结局是新发静脉血栓栓塞（深静脉血栓形成和/或肺栓塞）和血肿扩大，定义为基线血肿显著增大或新发血肿发生。将包括随机和非随机比较研究。将提取参与者特征、研究设计、干预措施细节和结局的数据。使用 Cochrane 偏倚风险工具和 Robins-I 工具评估研究质量。将根据所有可用的直接和间接证据进行贝叶斯网络荟萃分析，以比较干预措施。如果网络荟萃分析的传递性假设不能成立，我们将进行定性评估。
由于不会收集原始数据，因此不需要正式的伦理。本研究的结果将通过会议演讲和同行评审出版物进行传播。在临床实践中存在平衡的情况下，本研究的结果可能有助于确定哪种治疗干预措施在预防静脉血栓栓塞方面最有效。
PROSPERO 注册号：CRD42018090960。
