Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism: AYKAN Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02029456
• Other study ID #: 538.38792-903/6190
• Status: Recruiting
• Phase: Phase 4
• First received: November 17, 2013
• Last updated: January 7, 2014
• Start date: June 2011
• Est. completion date: August 2014

Study information

• Verified date: January 2014
• Source: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
• Contact: Ahmet Ç Aykan, MD
• Phone: 905058689461
• Email: ahmetaykan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Republic of Turkey: Ministery of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours

Locations

Country	Name	City	State
Turkey	Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Özkan M, Çakal B, Karakoyun S, Gürsoy OM, Çevik C, Kalçik M, Oguz AE, Gündüz S, Astarcioglu MA, Aykan AÇ, Bayram Z, Biteker M, Kaynak E, Kahveci G, Duran NE, Yildiz M. Thrombolytic therapy for the treatment of prosthetic heart valve thrombosis in pregnanc — View Citation

Özkan M, Gündüz S, Biteker M, Astarcioglu MA, Çevik C, Kaynak E, Yildiz M, Oguz E, Aykan AÇ, Ertürk E, Karavelioglu Y, Gökdeniz T, Kaya H, Gürsoy OM, Çakal B, Karakoyun S, Duran N, Özdemir N. Comparison of different TEE-guided thrombolytic regimens for pr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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.	Yes
Primary	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	No
Primary	Right Ventricular dysfunction	Right ventricular dysfunction detected by transthoracic echocardiography: Decreased right ventricular diameter (at least 25% decrease of Right ventricle/Left ventricle diameter); Tricuspid annular plane systolic excursion>16mm); s'> 10.0 cm/s; Tissue Doppler derived right ventricle myocardial performance index>0.55	participants will be followed for the duration of hospital stay, an expected average of 7 days	No
Primary	Restoration of hemodynamic status	Systolic blood pressure >100mmHG	6 hours after the beginning of thrombolytic therapy	Yes
Secondary	Pulmonary hypertension	Pulmonary artery systolic pressure >40mmHg	6 month	No
Secondary	Right ventricular dysfunction	Tricuspid annular plane systolic excursion >16mm; s'> 10.0 cm/s; Tissue Doppler derived right ventricle myocardial performance index>0.55; Right ventricle/Left ventricle diameter <1	6 months	No