Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis
|ClinicalTrials.gov Identifier: NCT02243839|
Recruitment Status : Unknown
Verified September 2014 by MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital.
Recruitment status was: Recruiting
First Posted : September 18, 2014
Last Update Posted : September 18, 2014
|Condition or disease||Intervention/treatment|
|Obstructive Thrombus||Drug: Thrombolytic Therapy Procedure: Surgery|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
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
Redo valve surgery is performed for obstructive valve thrombosis
- Thrombolytic success [ Time Frame: Up to 10 days ]
In the absence of fatal or nonfatal major complications;
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
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243839
|Kosuyolu Kartal Heart Training and Research Hospital||Recruiting|
|İstanbul, Turkey, 34844|
|Contact: Mehmet Özkan, Prof 905322551512 email@example.com|
|Principal Investigator: Mehmet Özkan, Professor|