Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Major, life threatening bleeding due to profuse bleeding
研究概览
简要总结
The aim of this work was to reduce the bleeding risk during thrombolysis using the viscoelastic blood coagulation tests.
详细描述
Patient data The patients' age, body measurements, general and coagulation-related medical history, SARS-COV2 status, APACHE-II, frailty score will be recorded.
Sampling times and examinations
The following considerations will be taken into account in the course of examining and providing care to the patients:
Imaging procedures:
CT angiography of the chest To confirm embolism and the results of lysis 12 to 24 hours after it is completed mandatory Echocardiography Right ventricle diameter mandatory views to be recorded: TAPSE mandatory parasternal longitudinal section IVC minimum and maximum diameter mandatory parasternal basal cross-section extent of tricuspid regurgitation mandatory apical 4 chamber estimated APsys mandatory subcostal 4 chamber D sign? mandatory IVC McConnel sign? optional 60/60 sign optional right heart thrombus optional Tricuspid annulus with reduced S' (<9.5 cm/s) tissue doppler optional Lower limb Doppler ultrasound Search for the origin of thromboembolism, preferably prior to lysis optional Table 2: Summary of the imaging procedures required for the study The condition for enrolment into the study is PE confirmed by CT angiography of the chest, with haemodynamic impact confirmed by echocardiography; the recording of the test in the IMPAX system is also a requirement. To assess the effectiveness of thrombolysis, echocardiography must be repeated after the lysis is completed, and then 12 to 24 hours later; the same is true for long-term follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary embolism confirmed by CT angiography of the chest, and planned systemic thrombolysis, taking into account the following:
- •For indications based on circulatory collapse or circulatory instability that persists despite circulatory support, a fixed dose will be delivered, preferably with coagulation monitoring. The rtPA dose is 0.6 mg/kg over 15 minutes (with a maximum dose of 50 mg) for circulatory collapse, and 100 mg over 2 hours for circulatory instability that persists despite circulatory support.
- •Otherwise, a regime relevant to our study is followed in the following cases in the individuals randomised to the study treatment group:
- •Haemodynamic instability resolved through inotropic and/or vasopressor therapy, or
- •In the event of right heart strain confirmed by echocardiography, and elevated cardiac biomarker (hs Troponin-T/NT-proBNP) in a haemodynamically stable patient, the regime to be followed will be determined by the monitoring results.
- •Exclusion criteria:
- •Failure to obtain informed consent from the patient (or from the closest relative of an incapacitated patient).
- •Coagulation tests included in the study protocol cannot be performed for any technical reason or samples cannot be collected.
- •Patients <18 years of age at the onset of pulmonary embolism.
- •Pregnancy.
- •The following risk factors are known or currently present in the patient:
- •Haemorrhagic stroke at any time in the medical history
- •Major trauma or head injury within the last three weeks
- •Incorrigible bleeding abnormality
- •Active bleeding that cannot be attenuated
- •Therapy refractory hypertension
- •Infective endocarditis
- •Patients lacking legal competence and the guardian or closest relative cannot be contacted.
排除标准
- 未提供
研究组 & 干预措施
Conventional thrombolysis group
A fixed dose of rtPA will be delivered, preferably with coagulation monitoring. The rtPA dose is 0.6 mg/kg over 15 minutes (with a maximum dose of 50 mg) for circulatory collapse, and 100 mg over 2 hours for circulatory instability that persists despite circulatory support
干预措施: Alteplase Injectable Product (Drug)
ClotPro-controlled variable dose of thrombolytic treatment.
A variable dose will be delivered, according to ClotPro EX, IN, AP, FIB, ECA, RVV, TPA results. The starting rtPA dose is 0.15-0.04 mg/kg in bolus, the starting maintaining dose for the first lysis hour the same. ClotPro tests is made in every 1 h treatment. The maintaining rtPA dose if it is needed, will be increased, till EX, IN, ECA efficient lysis could be detected. On the other hand the reduction of the maintaining dose was permitted based on FIB MCF alarming decline. The thrombolysis treatment is stopped if the circulatory instability and/or circulatory support ceased. Based on FIB MCF results fibrinogen concentrate coadministration on safety reason is permitted.
干预措施: Alteplase Injectable Product (Drug)
结局指标
主要结局
Major, life threatening bleeding due to profuse bleeding
时间窗: during the treatment with tPA (on the control arm 2 hours, on the intervention arm variable > 2 hours)
Hemorrhagic shock due to profuse bleeding: * hemoglobin reduction \> 30 g/l AND * Systolic blood pressure \< 90 mmHg OR * Reduction in systolic blood pressure \> 40 mmHg OR * Preserved systolic blood pressure achieved through increased dose of inotropic/vasopressor therapy
Major, life threatening bleeding due to intracranial haemorrhage
时间窗: during the treatment with tPA (on the control arm 2 hours, on the intervention arm variable > 2 hours)
Intracranial hemorrhage - new onset of neurological symptoms
Minor bleeding: Haemoglobin reduction > 10g/l during the treatment
时间窗: during the treatment with tPA (on the control arm 2 hours, on the intervention arm variable > 2 hours)
Haemoglobin reduction \> 10g/l, but less, than 30 g/l
次要结局
- Efficiency - Short therm: hemodynamic stabilization(36 hours after treatment)
- Efficiency - Short therm: significant regression or absence of embolus mass on post treatment pulmonary angio CT scan(24 hours after treatment)
- Efficiency - Long therm: further improvement on pulmonary CT scan(One month after the treatment)
- Efficiency - Long therm: absence of right hearth failure on echocardiography(One year after the treatment)
- Efficiency - Long therm: improvement on 6 minutes walking test(One year after the treatment)
研究者
Janos Fazakas MD, PhD
Associate Professor
Semmelweis University