Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

Official title

Evaluation of the Standard Catheter-directed Thrombolysis (SCDT) Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

Overview

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

Interventions

• Combination product Standard Catheter-Directed Low Dose Thrombolysis
  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
• Drug Standard Anticoagulation
  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

Primary outcome measures

• A decrease in the ratio of RV/LV diameters [Time frame: 48 ± 6 hours]

Secondary outcome measures (6)

• Mortality [Time frame: 90 days]
• Cardiorespiratory decompensation or collapse [Time frame: 7 days]
• Major bleeding events [Time frame: 7 days]
• PE thrombus load reduction [Time frame: 48 hours]
• The degree of residual pulmonary artery thrombosis with perfusion deficiency [Time frame: 180 days]
• Post-pulmonary embolism syndrome formation [Time frame: 180 days]

Eligibility criteria

Inclusion criteria

• Age > 18 years
• Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom onset < 14 days prior
• Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio >1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level
• Signed informed consent

Exclusion criteria

• High-risk pulmonary embolism
• Thrombus in the heart chambers on TTE
• Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding currently or within the previous 6 months, hemorrhagic diathesis; diseases of the central nervous system (including neoplasms, aneurysm, surgery on the brain or spinal cord); intracranial (including subarachnoid) hemorrhage currently or in history, suspicion of hemorrhagic stroke; severe uncontrolled arterial hypertension; major surgery or major trauma within the previous 3 months, recent traumatic brain injury; labor during the previous 10 days; severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; confirmed peptic ulcer of the stomach or duodenum within the last 3 months; arterial aneurysms, congenital anomalies of arteries/veins;
• Haemoglobin level < 70 g/L, platelet count ≤ 100 x 109
• Allergic to alteplase or UFH or contrast allergy
• Pregnant or breastfeeding
• Clinically significant malignancies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Russia · 1 center

• Almazov National Medical Research Centre — Saint Petersburg

Publications

• Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in co PMID 31504429

Identifiers

NCT: NCT06487052 · 1511-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗