An interventional study of Standard Catheter-Directed Low Dose Thrombolysis and Standard Anticoagulation in Pulmonary Embolism Acute, sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Not applicable, Interventional, and Treatment
A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 100 is below the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health is the lead sponsor of 30 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Local, standard catheter-directed thrombolysis with a total alteplase dose of 10 mg (for unilateral lesion) or 20 mg (for bilateral lesion) administered over 9 hours
Combination Product: Standard Catheter-Directed Low Dose Thrombolysis
Therapy with UFH with targeted аPTT lasts for 24 hours (no more than 48 hours in total). Then the change to oral anticoagulants is performed.
Drug: Standard Anticoagulation
Using femoral or jugular vein access the mechanical blood clots fragmentation by PigTail 6F catheter circular rotational movements. For unilateral thromboembolism, the PigTail catheter is positioned in the obstructed branch of the pulmonary artery, 1 mg of alteplase is injected as a bolus, followed by a micro-jet injection of 1 mg/hour. For bilateral thromboembolism, the PigTail catheter is positioned in the pulmonary trunk with a bolus of 2 mg alteplase followed by an infusion of 2 mg/hour. The total duration of infusion will be 9 hours, the total dose of alteplase will be 10 mg for unilateral lesions and 20 mg for bilateral lesions. During the alteplase infusion, unfractionated heparin is continued with a target activated partial thromboplastin time (aPTT) of 50 to 60 seconds. After completion of the procedure, UFH therapy is continued for 24 hours, followed by a change to oral anticoagulants.
Therapy with UFH with targeted аPTT lasts for 24 hours (no more than 48 hours in total). Then the change to oral anticoagulants is performed
A decrease in the ratio of RV/LV diameters
A decrease in the ratio of RV/LV diameters by 20% or more from the initial value 48 ± 6 hours after initiation of therapy
Time frame: 48 ± 6 hours
Mortality
Mortality
Time frame: 90 days
Cardiorespiratory decompensation or collapse
necessity of inotropic and vasopressor support; cardiac arrest or need for CPR; obstructive shock, placement on extracorporeal membrane oxygenation (ECMO), intubation, or initiation of non-invasive mechanical ventilation
Time frame: 7 days
Major bleeding events
International Society on Thrombosis and Hemostasis (ISTH) major bleeding
Time frame: 7 days
PE thrombus load reduction
Qanadli score by CT-scan
Time frame: 48 hours
The degree of residual pulmonary artery thrombosis with perfusion deficiency
The degree of residual pulmonary artery thrombosis with perfusion deficiency by CT-scan
Time frame: 180 days
Post-pulmonary embolism syndrome formation
The presence of symptomatic pulmonary artery residual thrombosis
Time frame: 180 days
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Jan 2027, 36 months after the start.
Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 36 months is above that.
Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health