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Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02243839
First Posted: September 18, 2014
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
  Purpose
Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity The best treatment of PVT is controversial, although surgery and thrombolysis options have been available. In this randomized and multicenter study, the investigators compared thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic valve thrombosis.

Condition Intervention
Obstructive Thrombus Drug: Thrombolytic Therapy Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital:

Primary Outcome Measures:
  • Thrombolytic success [ Time Frame: Up to 10 days ]

    In the absence of fatal or nonfatal major complications;

    Obstructive thrombus:

    Doppler documentation of the resolution of increased gradient and decreased valve area.

    Clinical improvement in symptoms. Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3

    Nonobstrucive thrombus:

    Complete success: ≥75% reduction in thrombus area. Partial success: 50%-75% reduction in thrombus area


  • Non-fatal complications for thrombolytic therapy [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]

    Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion.

    Nonfatal minor complication: Bleeding without need for transfusion, TIA.


  • Successful Surgery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months ]
    Successful redo valve surgery in the absence of fatal and non fatal major complications.

  • Complications for surgery [ Time Frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month ]
    Non fatal major complications: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, pericardial tamponade, sepsis, pacemaker requirement, mediastinitis, wound infections, acute renal failure Minor complications: bleeding requiring transfusion, plevral effusion, pericardial effusion without tamponade

  • In hospital mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    All cause in-hospital mortality.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thrombolytic therapy
In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra-slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours.
Drug: Thrombolytic Therapy
Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis
Active Comparator: Surgery
In the second arm, redo valve surgery is performed for obstructive valve thrombosis. Intraoperative and postoperative results are recorded
Procedure: Surgery
Redo valve surgery is performed for obstructive valve thrombosis

Detailed Description:
Two different randomization group have been defined and patients with obstructive prosthetic valve thrombosis are included in each group randomly. In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours. In the second arm, redo valve surgery is performed for obstructive valve thrombosis. This multicenter study is conducted in Cardiology and Cardiovascular Surgery Departments of Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey, Siyami Ersek Heart Training and Research Hospital, Istanbul, Turkey, Ankara Heart Training and Research Hospital, Ankara, Turkey, İzmir Atatürk Heart Training and Research Hospital, İzmir, Turkey, Erzurum Atatürk University Faculty of Medicine, Erzurum, Turkey, Diyarbakır Dicle University Faculty of Medicine, Diyarbakır, Turkey and Kars Kafkas University Faculty of Medicine, Kars, Turkey. Informed consent is taken from all patients.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obstructive prosthetic valve thrombosis

Exclusion Criteria:

  • Non-obstructive prosthetic valve thrombosis
  Contacts and Locations
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): NCT02243839


Locations
Turkey
Kosuyolu Kartal Heart Training and Research Hospital Recruiting
İstanbul, Turkey, 34844
Contact: Mehmet Özkan, Prof    905322551512    memoozkan1@gmail.com   
Principal Investigator: Mehmet Özkan, Professor         
Sponsors and Collaborators
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
  More Information

Responsible Party: MEHMET OZKAN, Professor, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02243839     History of Changes
Other Study ID Numbers: KOSUYOLU3
First Submitted: September 12, 2014
First Posted: September 18, 2014
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital:
Prosthetic valve
Thrombosis
Surgery
Thrombolytic therapy
Transesophageal echocardiography

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action