2/2 Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT Trial) –DCC
2/2 肺栓塞:导管定向治疗血栓清除(PE-TRACT 试验)—DCC
基本信息
- 批准号:10448731
- 负责人:
- 金额:$ 62.28万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-01 至 2028-08-31
- 项目状态:未结题
- 来源:
- 关键词:Activities of Daily LivingAcuteAnticoagulant therapyAnticoagulationBenefits and RisksBerryBiometryBlindedBlood PressureBudgetsCardiopulmonaryCathetersCessation of lifeClinicalClinical TrialsClinical Trials Data Monitoring CommitteesClinical Trials DesignCoagulation ProcessConsultationsCost Effectiveness AnalysisDangerousnessDataData AnalysesData CollectionData Coordinating CenterData SetDatabasesDeteriorationDiseaseDoseEconomicsEnrollmentEnsureEventExcisionExercise TestFibrinolytic AgentsFutilityGatekeepingGoalsHealthHeartHemorrhageInfrastructureMeasuresMethodologyMissionNational Heart, Lung, and Blood InstituteNew YorkOutcomeOutcome StudyOxygen ConsumptionPatientsPhasePragmatic clinical trialProceduresProcessProtocol CompliancePublic HealthPublicationsPulmonary EmbolismPulmonary artery structureQuality ControlQuality of lifeQuality-Adjusted Life YearsRandomizedRandomized Controlled TrialsRecurrenceReportingResearch DesignResourcesRight Ventricular DysfunctionRight Ventricular FunctionRiskSample SizeSecurityStandardizationStatistical Data InterpretationTestingTherapy trialThrombolytic TherapyThrombusTimeWalkingWorkWritingadjudicationadverse event monitoringclinical centerclinical practicecostdata de-identificationdata integritydata qualitydata repositorydata resourcedesigndisabilityeffectiveness studyefficacy outcomesexercise capacityexperiencefeasibility trialfollow-upfunctional statusimprovedincremental cost-effectivenessinnovationopen labelpreventprimary outcomerandomized trialsafety outcomesscreeningthrombolysistreatment grouptrial designvenous thromboembolism
项目摘要
PROJECT SUMMARY
The optimal management of patients with submassive pulmonary embolism (PE), who have right heart
dysfunction but a normal blood pressure, is uncertain. These patients are at risk for poor short-term outcomes,
suffer from reduced functional capacity, and have lower quality of life over the long term. While systemic
thrombolysis reduces clinical deterioration from PE, this benefit is offset by substantial increases in major and
intracranial bleeding. Catheter-directed therapy (CDT), which dissolves pulmonary artery thrombus with a
much lower dose of thrombolytic drug, may be as effective as systemic thrombolytic therapy without
substantially increasing bleeding, but it has risks and is costly, and it is not known if it improves
cardiopulmonary heath, particularly over the long term.
We therefore plan to conduct an open-label, assessor-blinded, randomized trial, the Pulmonary Embolism:
Thrombus Removal with Catheter-Directed Therapy (PE-TRACT) Study, to compare CDT with No-CDT in
up to 500 patients with submassive PE. The trial is adaptive, and could result in enrollment being stopped
early for superior efficacy or for futility at an interim analysis. There will be two primary efficacy outcomes: peak
oxygen consumption at 3 months (short-term) and New York Heart Association (NYHA) class at 12 months
(long-term), analyzed sequentially using a gatekeeping approach; for NYHA class to be compared, peak
oxygen consumption must first be shown to be increased by CDT (P<0.05). The primary safety outcome will be
major bleeding within 30 days of randomization. The Data Coordinating Center, led by experts with deep
experience in adaptive and pragmatic clinical trial design and implementation, will oversee all aspects of study
design, implementation, and analysis, and will provide state-of-the-art data collection and quality control
infrastructure, reporting to the independent Data and Safety Monitoring Board, and provision of data and
resources to the public. The PE-TRACT Study will change clinical practice: if CDT is effective and safe, it will
become part of standard therapy for patients with submassive PE; if not, a risky and costly therapy will be
avoided. Hence, either study outcome will improve public health and advance the NHLBI’s mission
项目摘要
右心次大面积肺栓塞(PE)患者的最佳治疗
功能障碍但血压正常,是不确定的。这些患者有短期预后不良的风险,
功能能力下降,长期生活质量下降。虽然系统性
溶栓减少了PE的临床恶化,但这一获益被主要和
颅内出血导管导向治疗(CDT),它溶解肺动脉血栓,
低得多剂量的溶栓药物,可能与全身溶栓治疗一样有效,
大幅度增加出血,但它有风险,成本高,而且不知道它是否会改善
心肺健康,特别是长期。
因此,我们计划进行一项开放标签、评估者设盲、随机试验,即肺栓塞:
导管引导治疗血栓清除(PE-TRACT)研究,比较CDT与无CDT患者的
多达500例次大面积PE患者。该试验是适应性的,可能导致招募停止
在中期分析时,因上级疗效或无效而提前。将有两个主要疗效结局:峰值
3个月时的耗氧量(短期)和12个月时的纽约心脏协会(NYHA)分级
(长期),使用把关方法进行顺序分析;对于要比较的NYHA分级,峰值
氧耗量必须首先显示出CDT增加(P<0.05)。主要安全性结局将是
随机化前30天内发生大出血。数据协调中心,由专家领导,
在适应性和实用的临床试验设计和实施方面的经验,将监督研究的各个方面
设计、实施和分析,并将提供最先进的数据收集和质量控制
基础设施,向独立的数据和安全监测委员会报告,以及提供数据和
资源给公众。PE-TRACT研究将改变临床实践:如果CDT有效且安全,
成为亚大块PE患者标准治疗的一部分;如果不是,
避免了因此,任何一项研究结果都将改善公众健康,推进NHLBI的使命
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
THADDEUS TARPEY其他文献
THADDEUS TARPEY的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('THADDEUS TARPEY', 18)}}的其他基金
Identifying Placebo Responders in Drug Treated Subjects
确定药物治疗受试者中的安慰剂反应者
- 批准号:
7154750 - 财政年份:2005
- 资助金额:
$ 62.28万 - 项目类别:
Identifying Placebo Responders in Drug Treated Subjects
确定药物治疗受试者中的安慰剂反应者
- 批准号:
7027013 - 财政年份:2005
- 资助金额:
$ 62.28万 - 项目类别:
Identifying Placebo Responders in Drug Treated Subjects
确定药物治疗受试者中的安慰剂反应者
- 批准号:
6920273 - 财政年份:2005
- 资助金额:
$ 62.28万 - 项目类别:
相似海外基金
Transcriptional assessment of haematopoietic differentiation to risk-stratify acute lymphoblastic leukaemia
造血分化的转录评估对急性淋巴细胞白血病的风险分层
- 批准号:
MR/Y009568/1 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Fellowship
Combining two unique AI platforms for the discovery of novel genetic therapeutic targets & preclinical validation of synthetic biomolecules to treat Acute myeloid leukaemia (AML).
结合两个独特的人工智能平台来发现新的基因治疗靶点
- 批准号:
10090332 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Collaborative R&D
Acute senescence: a novel host defence counteracting typhoidal Salmonella
急性衰老:对抗伤寒沙门氏菌的新型宿主防御
- 批准号:
MR/X02329X/1 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Fellowship
Cellular Neuroinflammation in Acute Brain Injury
急性脑损伤中的细胞神经炎症
- 批准号:
MR/X021882/1 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Research Grant
KAT2A PROTACs targetting the differentiation of blasts and leukemic stem cells for the treatment of Acute Myeloid Leukaemia
KAT2A PROTAC 靶向原始细胞和白血病干细胞的分化,用于治疗急性髓系白血病
- 批准号:
MR/X029557/1 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Research Grant
Combining Mechanistic Modelling with Machine Learning for Diagnosis of Acute Respiratory Distress Syndrome
机械建模与机器学习相结合诊断急性呼吸窘迫综合征
- 批准号:
EP/Y003527/1 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Research Grant
FITEAML: Functional Interrogation of Transposable Elements in Acute Myeloid Leukaemia
FITEAML:急性髓系白血病转座元件的功能研究
- 批准号:
EP/Y030338/1 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Research Grant
STTR Phase I: Non-invasive focused ultrasound treatment to modulate the immune system for acute and chronic kidney rejection
STTR 第一期:非侵入性聚焦超声治疗调节免疫系统以治疗急性和慢性肾排斥
- 批准号:
2312694 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Standard Grant
ロボット支援肝切除術は真に低侵襲なのか?acute phaseに着目して
机器人辅助肝切除术真的是微创吗?
- 批准号:
24K19395 - 财政年份:2024
- 资助金额:
$ 62.28万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
Acute human gingivitis systems biology
人类急性牙龈炎系统生物学
- 批准号:
484000 - 财政年份:2023
- 资助金额:
$ 62.28万 - 项目类别:
Operating Grants