隐蔽2:癌症接受姑息治疗患者的医院深静脉血栓检测研究的研究方案。
HIDDEN2: Study protocol for the hospital deep vein thrombosis detection study in patients with cancer receiving palliative care.
发表日期:2023 Sep 05
作者:
Terri Kitson, Emma Osborne, Simon Noble, Nikki Pease, Raza Alikhan, Catherine Bryant, Tristan Groves, Rebecca Wallace, Sarah Walker, Kathy Seddon, Deb Smith, Lawrence Raisanen, Joanna Smith, Ian Thomas, Laura Upton, Angela Casbard
来源:
MEDICINE & SCIENCE IN SPORTS & EXERCISE
摘要:
被急诊入院的医疗患者面临着静脉血栓栓塞(VTE)的风险。临床指南建议对那些高危VTE的患者进行抗凝治疗。VTE是癌症的常见后遗症,但指南对癌症作为独立危险因素的考虑很少,且在姑息治疗患者中的实用性尚不清楚。安宁病房的深静脉血栓(DVT)检测研究(HIDDen)报告称,预后差的姑息护理患者中无症状髂股动脉 DVT 的患病率为28%,这对姑息护理环境下抗凝治疗的实用性提出了质疑。然而,大多数接受姑息护理的癌症住院患者是从急性医疗环境中入院的,因此他们的VTE风险因素可能与进入安宁病房的患者有所不同。为了更好地了解接受姑息护理的癌症患者在作为急诊医疗紧急情况入院时VTE的患病率和行为特征,我们进行了一个多中心观察队列研究。研究范围包括英国威尔士南部的二级保健急诊医院。我们计划招募232名18岁及以上的不可治愈癌症患者和/或正在接受姑息或最佳支持治疗的患者,他们急诊入院。患者在登记后最长将进行6个月的随访。主要观察指标为下肢DVT的存在。次要观察指标包括被归因于DVT或肺栓塞的症状负担、患者PS、患者人口统计学特征,以及在登记后90天内是否发生新的VTE。研究统计分析计划将记载分析、方法和程序。研究已获得威尔士研究伦理委员会的伦理批准,编号22/WA/0037(IRAS 306352)-主要试验结果将在尽可能短的时间内进行分析,并与调查人员和赞助方网站共享;试验数据访问申请将经赞助方审查程序审议。© 作者(或其雇主)2023年。在CC BY-NC下允许重新使用。不允许商业再利用。由BMJ出版。
Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices.To better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency.Multicentre, observational cohort study.Secondary care acute hospitals in South Wales, UK.We plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration.Presence of lower extremity DVT.Symptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration.The study statistical analysis plan will document analysis, methodology and procedures.Ethical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)-the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.