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

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ClinicalTrials.gov Identifier: NCT02029456
Recruitment Status : Unknown
Verified January 2014 by AHMET CAGRI AYKAN, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
AHMET CAGRI AYKAN, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism: AYKAN Trial
Study Start Date : June 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: Low dose prolonged infusion arm
Low dose prolonged infusion of tPA arm (25mg Actilyse in 6 hours)
Drug: 25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours



Primary Outcome Measures :
  1. All cause in hospital mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    Death occured during hospitalization period.

  2. Major complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days. ]
    Major bleeding, intracranial bleeding, resuscitated cardiac arrest, thromboembolism and stroke are described as major complications.

  3. Development of pulmonary hypertension [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    Pulmonary artery systolic pressure >40mmHg measured by transthoracic echocardiography prior to discharge was described as pulmonary hypertension.

  4. Right Ventricular dysfunction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days ]

    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

  5. Restoration of hemodynamic status [ Time Frame: 6 hours after the beginning of thrombolytic therapy ]
    Systolic blood pressure >100mmHG


Secondary Outcome Measures :
  1. Pulmonary hypertension [ Time Frame: 6 month ]
    Pulmonary artery systolic pressure >40mmHg

  2. Right ventricular dysfunction [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029456


Contacts
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Contact: Ahmet Ç Aykan, MD 905058689461 ahmetaykan@yahoo.com

Locations
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Turkey
Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital Recruiting
Trabzon, Turkey, 61040
Principal Investigator: AHMET Ç AYKAN, MD         
Sponsors and Collaborators
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Investigators
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Study Chair: Ahmet Ç AYKAN, MD Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Publications of Results:
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Responsible Party: AHMET CAGRI AYKAN, Medical Doctor,, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02029456    
Other Study ID Numbers: 538.38792-903/6190
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014
Keywords provided by AHMET CAGRI AYKAN, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital:
Massive Pulmonary embolism
thrombolytic therapy
high risk
elderly
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action