Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose prolonged infusion arm | Experimental | Low dose prolonged infusion of tPA arm (25mg Actilyse in 6 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause in hospital mortality | Death occured during hospitalization period. | 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. | 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. | 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:
| participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Restoration of hemodynamic status | Systolic blood pressure >100mmHG | 6 hours after the beginning of thrombolytic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary hypertension | Pulmonary artery systolic pressure >40mmHg | 6 month |
| Right ventricular dysfunction |
|
Not provided
Inclusion Criteria:
Patients with massive PE aged 18 years or older with confirmed PE and able to give informed consent will be included in the study. PE is defined according to current guidelines as adult patients presenting with signs and symptoms suggestive of PE plus imaging documentation on computed tomography angiography. Massive PE was defined as acute PE with sustained hypotension (systolic blood pressure<90 mm Hg for at least 15 minutes or requiring inotropic support, not due to a cause other than PE, such as arrhythmia, hypovolemia, sepsis, or left ventricular [LV] dysfunction), pulselessness, or persistent profound bradycardia (heart rate<40 bpm with signs or symptoms of shock).
Exclusion Criteria:
Patients with prior intracranial hemorrhage, known structural intracranial cerebrovascular disease (eg, arteriovenous malformation), known malignant intracranial neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent surgery encroaching on the spinal canal or brain, and recent significant closed-head or facial trauma with radiographic evidence of bony fracture or brain injury were excluded from the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmet Ç Aykan, MD | Contact | 905058689461 | ahmetaykan@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmet Ç AYKAN, MD | Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital | Recruiting | Trabzon | 61040 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23812180 | Result | Ozkan M, Cakal B, Karakoyun S, Gursoy OM, Cevik C, Kalcik M, Oguz AE, Gunduz S, Astarcioglu MA, Aykan AC, Bayram Z, Biteker M, Kaynak E, Kahveci G, Duran NE, Yildiz M. Thrombolytic therapy for the treatment of prosthetic heart valve thrombosis in pregnancy with low-dose, slow infusion of tissue-type plasminogen activator. Circulation. 2013 Jul 30;128(5):532-40. doi: 10.1161/CIRCULATIONAHA.113.001145. Epub 2013 Jun 28. | |
| 23489534 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Result |
| Ozkan M, Gunduz S, Biteker M, Astarcioglu MA, Cevik C, Kaynak E, Yildiz M, Oguz E, Aykan AC, Erturk E, Karavelioglu Y, Gokdeniz T, Kaya H, Gursoy OM, Cakal B, Karakoyun S, Duran N, Ozdemir N. Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial. JACC Cardiovasc Imaging. 2013 Feb;6(2):206-16. doi: 10.1016/j.jcmg.2012.10.016. |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
Not provided
Not provided