The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE.
Pulmonary embolism (PE) is life threatening disease requiring early diagnosis and treatment. Thrombolytic therapy (TT) is required in patients with massive PE. PE has a high mortality but the in-hospital all-cause case mortality rates were lower in unstable patients who received TT than those who did not. However, it was reported that minority (nearly 30%) of unstable patients received thrombolytic therapy. The reason that majority of unstable patients failed to receive thrombolytic therapy is unclear. The higher rates of complications including the life threatening bleeding may be a reason of reluctance in the use of TT. The lungs are the only organ receiving the entire cardiac output. Therefore, they are the point of convergence for the entire molecules of the thrombolytic agent, independent from the route of administration. So that lower doses of the TT might be effective in PE, with the additional benefits of enhancing its safety profile. The percutaneous endovenous intervention for deep venous thrombosis has suggested an exquisitely favorable pulmonary response to low-dose thrombolysis. The aim of the present study was to assess the effects of low-dose (25mg) prolonged administration (in 6 hours) of tissue type plasminogen activator (tPA) on in-hospital mortality and outcomes in patients with massive PE. The primary end points consisted of in hospital all cause mortality, major complications, pulmonary hypertension and right ventricular dysfunction. Secondary points are all cause mortality, pulmonary hypertension and right ventricular dysfunction at 6 month.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Trabzon, Turkey (Türkiye)
RECRUITINGAll cause in hospital mortality
Death occured during hospitalization period.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Major complications
Major bleeding, intracranial bleeding, resuscitated cardiac arrest, thromboembolism and stroke are described as major complications.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days.
Development of pulmonary hypertension
Pulmonary artery systolic pressure \>40mmHg measured by transthoracic echocardiography prior to discharge was described as pulmonary hypertension.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Right Ventricular dysfunction
Right ventricular dysfunction detected by transthoracic echocardiography: 1. Decreased right ventricular diameter (at least 25% decrease of Right ventricle/Left ventricle diameter) 2. Tricuspid annular plane systolic excursion\>16mm) 3. s'\> 10.0 cm/s 4. Tissue Doppler derived right ventricle myocardial performance index\>0.55
Time frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
Restoration of hemodynamic status
Systolic blood pressure \>100mmHG
Time frame: 6 hours after the beginning of thrombolytic therapy
Pulmonary hypertension
Pulmonary artery systolic pressure \>40mmHg
Time frame: 6 month
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Right ventricular dysfunction
1. Tricuspid annular plane systolic excursion \>16mm 2. s'\> 10.0 cm/s 3. Tissue Doppler derived right ventricle myocardial performance index\>0.55 4. Right ventricle/Left ventricle diameter \<1
Time frame: 6 months