Low Dose Prolonged Infusion of Tissue Type Plasminogen Activator Therapy in Massive Pulmonary Embolism
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJanuary 8, 2014
January 1, 2014
2.8 years
November 17, 2013
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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: 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
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
Secondary Outcomes (2)
Pulmonary hypertension
6 month
Right ventricular dysfunction
6 months
Study Arms (1)
Low dose prolonged infusion arm
EXPERIMENTALLow dose prolonged infusion of tPA arm (25mg Actilyse in 6 hours)
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Trabzon, 61040, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 23812180RESULTOzkan 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.
PMID: 23489534RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmet Ç AYKAN, MD
Department of Cardiology, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor,
Study Record Dates
First Submitted
November 17, 2013
First Posted
January 8, 2014
Study Start
June 1, 2011
Primary Completion
March 1, 2014
Study Completion
August 1, 2014
Last Updated
January 8, 2014
Record last verified: 2014-01