PDF(Pubmed)
Abstract：
BACKGROUND: Central venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock.
METHODS: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers.
BACKGROUND: Ethics approval has been provided by Children\'s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences.
BACKGROUND: ACTRN12622000499785.
METHODS: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers.
BACKGROUND: Ethics approval has been provided by Children\'s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences.
BACKGROUND: ACTRN12622000499785.
摘要：
背景：中心静脉接入装置（CVAD）通常用于治疗儿科癌症患者。导管锁定是预防CVAD相关不良事件的常规干预措施。如感染，闭塞和血栓形成。虽然实验室和临床数据很有希望，tetra-EDTA（T-EDTA）尚未被严格评估或作为导管锁定引入癌症治疗。
方法：这是一个双臂协议，在澳大利亚和新西兰的7家医院进行的优势1型混合有效性实施随机对照试验.随机化将以3:2的比例在盐水(肝素化盐水和生理盐水)和T-EDTA组之间,随机改变大小为10或20的区块，并按（1）医疗机构分层；（2）CVAD类型和（3）自插入以来的停留时间。在生理盐水组中，将在正常和肝素盐水之间进行随机分配。参与者可以在插入新的CVAD时被重新招募和随机化。有效性的主要结果将是CVAD相关血流感染（CABSI）的复合，CVAD驻留期间或移除时的CVAD相关血栓形成或CVAD闭塞。次要结果将包括CABSI，CVAD相关血栓形成,CVAD故障,偶发性无症状CVAD相关血栓形成，其他不良事件,与健康相关的生活质量，医疗费用和死亡率。为了实现主要结果的90％功效（α=0.05），需要720份招聘数据。将采用混合方法方法从临床医生和医疗保健购买者的角度探索实施环境。
背景：昆士兰儿童健康医院和卫生服务人类研究伦理委员会（HREC）（HREC/22/QCHQ/81744）和昆士兰大学HREC（2022/HE000196）已提供伦理批准，并随后在所有地点获得了治理批准。在参与之前，需要获得替代决策者或法定监护人的知情同意。此外,也可以从成熟的未成年人那里获得同意，根据研究地点的立法要求。主要试验和子研究将由研究人员撰写，并在同行评审的期刊上发表。研究结果还将由研究人员通过当地卫生和临床试验网络传播，并在会议上介绍。
背景：ACTRN12622000499785。
方法：这是一个双臂协议，在澳大利亚和新西兰的7家医院进行的优势1型混合有效性实施随机对照试验.随机化将以3:2的比例在盐水(肝素化盐水和生理盐水)和T-EDTA组之间,随机改变大小为10或20的区块，并按（1）医疗机构分层；（2）CVAD类型和（3）自插入以来的停留时间。在生理盐水组中，将在正常和肝素盐水之间进行随机分配。参与者可以在插入新的CVAD时被重新招募和随机化。有效性的主要结果将是CVAD相关血流感染（CABSI）的复合，CVAD驻留期间或移除时的CVAD相关血栓形成或CVAD闭塞。次要结果将包括CABSI，CVAD相关血栓形成,CVAD故障,偶发性无症状CVAD相关血栓形成，其他不良事件,与健康相关的生活质量，医疗费用和死亡率。为了实现主要结果的90％功效（α=0.05），需要720份招聘数据。将采用混合方法方法从临床医生和医疗保健购买者的角度探索实施环境。
背景：昆士兰儿童健康医院和卫生服务人类研究伦理委员会（HREC）（HREC/22/QCHQ/81744）和昆士兰大学HREC（2022/HE000196）已提供伦理批准，并随后在所有地点获得了治理批准。在参与之前，需要获得替代决策者或法定监护人的知情同意。此外,也可以从成熟的未成年人那里获得同意，根据研究地点的立法要求。主要试验和子研究将由研究人员撰写，并在同行评审的期刊上发表。研究结果还将由研究人员通过当地卫生和临床试验网络传播，并在会议上介绍。
背景：ACTRN12622000499785。
