Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests (NCT06667882) | Clinical Trial Compass
CompletedNot Applicable
Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests
Hungary33 participantsStarted 2021-12-17
Plain-language summary
The aim of this work was to reduce the bleeding risk during thrombolysis using the viscoelastic blood coagulation tests.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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…
What they're measuring
1
Major, life threatening bleeding due to profuse bleeding
Timeframe: during the treatment with tPA (on the control arm 2 hours, on the intervention arm variable > 2 hours)
2
Major, life threatening bleeding due to intracranial haemorrhage
Timeframe: during the treatment with tPA (on the control arm 2 hours, on the intervention arm variable > 2 hours)
3
Minor bleeding: Haemoglobin reduction > 10g/l during the treatment
Timeframe: during the treatment with tPA (on the control arm 2 hours, on the intervention arm variable > 2 hours)