OW DOSE THROMBOLYSIS, ULTRASOUND ASSISTED THROMBOLYSIS OR HEPARIN FOR INTERMEDIATE HIGH RISK PULMONARY EMBOLISM - STRATIFY

Copenhagen University Hospital Rigshospitalet0 个研究点目标入组 210 人开始时间: 2018年5月25日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•1)Age = 18 years
•2)Informed consent for trial participation
•3)Intermediate high-risk PE according to ESC criteria
•4)Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
•5)14 days of symptoms or less
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 70

•1)Altered mental state (GCS < 14)
•2)No qualifying CT angiography performed (> 24 hour since CT angiography)
•3)Females of child bearing potential, unless negative HCG test is present
•4)Thrombolysis for PE within 14 days of randomization
•5)Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
•6)Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
•7)Comorbidity making 6 months survival unlikely
•8)Absolute contraindications for thrombolysis
•a.Hemorrhagic stroke or stroke of unknown origin at any time
•b.Ischemic stroke in the preceding 6 months
•c.Central nervous system damage or neoplasms
•d.Recent major trauma/surgery/head injury in the preceding 3 weeks
•e. Gastrointestinal bleeding within the last month
•f.Known bleeding risk
•Relative contraindications do not preclude randomization. Relative contraindications include: Transient ischemic attack in the preceding 6 months, Oral anticoagulant therapy, Pregnancy, or within one week pPost partum, Non-compressible puncture site, Traumatic resuscitation, Refractory hypertension (systolic blood pressure >180 mm Hg), Advanced liver disease, Infective endocarditis, Active peptic ulcer

发起方

Copenhagen University Hospital Rigshospitalet