Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 30 day mortality and bleeding events
研究概览
简要总结
The aim of investigators was to study the effect and safety of Thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards Mortality and bleeding events.
详细描述
InvestIgators aimed to determine the effect of thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards mortality and bleeding events.
Study design : randomized clinical study conducted Ain Shams University Hospitals over 2 years duration , included 100 participants divided into two groups; control group (50) and study group (50).
Participants assigned to the control group received standard treatment in the form of anticoagulation (intravenous unfractionated heparin) whole participant assigned to control group received thrombolytic therapy (streptokinase or recombinant tissue plasminogen activator) Investigators performed baseline echocardiography for all participants before receiving treatment and assessment of bleeding risk using HASBLED score Follow up of participants' vital data was done in a monitored care unit Participants were assessed one month later for dyspnea and its grade and follow up echocardiography was done also.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intermediate high risk pulmonary embolism diagnosed according to clinical probability using revised Geneva Score and diagnosis confirmed by echocardiography and Troponin I or T level and CT pulmonary angiography
排除标准
- •o High risk PE
- •Intermediate low risk PE
- •low risk PE
- •Patients with left ventricular systolic dysfunction (ischemic or non-ischemic etiology)
- •Patients with chronic lung diseases (obstructive or restrictive)
- •Patients with contraindications to thrombolysis:
- •History of haemorrhagic stroke or stroke of unknown origin
- •Ischaemic stroke in previous 6 months
- •Central nervous system neoplasm
- •Major trauma, surgery, or head injury in previous 3 weeks
- •Bleeding diathesis (known inherited bleeding disorder, for example, haemophilia, platelet count <50,000/uL)
- •Active bleeding
- •Transient ischaemic attack in previous 6 months
- •Oral anticoagulation
- •Pregnancy or first post-partum week
- •Non-compressible puncture sites
- •Traumatic resuscitation
- •Severe hypertension (systolic BP >180 mmHg)
- •Advanced liver disease
- •Infective endocarditis
- •Active Peptic ulcer
- •Patients who develop hypotension or bradycardia or allergic reaction requiring discontinuation of Streptokinase infusion.
- •Patients with HAS-BLED score greater than or equals 3 (high bleeding risk for thrombolysis)
研究组 & 干预措施
Control group
This arm will receive standard anticoagulation in the form of intravenous unfractionated heparin
干预措施: Unfractionated Heparin IV (Drug)
Study group
This arm will receive thrombolytic therapy in the form of either streptokinase or recombinant tissue plasminogen activator
干预措施: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator (Drug)
结局指标
主要结局
30 day mortality and bleeding events
时间窗: 30 days for mortality and bleeding within hospital stay duration
Cardiac arrest due to pulmonary embolism (mortality) and major bleeding
次要结局
未报告次要终点