Department of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Division of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.
Sci Rep. 2019 Apr 10;9(1):5885. doi: 10.1038/s41598-019-42087-z.
The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.
Dex-CSDH 试验是一项针对有症状慢性硬脑膜下血肿患者的地塞米松随机、双盲、安慰剂对照试验。该试验首先进行了内部试点，其主要目的是评估多中心招募的可行性。同时还评估了主要结局数据的收集和安全性，保持了盲法。我们的目标是在 12 个月内从英国神经外科单位招募 100 名患者。试验参与者被随机分配接受为期 2 周的地塞米松或安慰剂治疗，同时接受标准治疗（可能包括手术）。试验的主要结局指标是 6 个月时改良 Rankin 量表。该试点提前达到目标；在试验开始后的九个月内招募了 100 名患者。47%的筛选患者同意入组。98%的患者收集了主要结局指标。独立数据监测和伦理委员会没有提出安全问题，只有 5 名患者退出了药物治疗。试点试验数据可以为实质性试验的设计和资源提供信息。这项内部试点成功地确定了招募的可行性。实现了极佳的随访率，并增加了探索性结局指标，以提高试验的科学价值。
