Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis

Not Applicable

• Conditions: Obstructive Thrombus
• Interventions: Procedure: Surgery; Drug: Thrombolytic Therapy

• Registration Number: NCT02243839
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-18
• Last Update Posted: 2014-09-18
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Obstructive prosthetic valve thrombosis

Exclusion Criteria

• Non-obstructive prosthetic valve thrombosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	In the second arm, redo valve surgery is performed for obstructive valve thrombosis. Intraoperative and postoperative results are recorded
Thrombolytic therapy	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.

Primary Outcome Measures

Name	Time	Method
Non-fatal complications for thrombolytic therapy	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.
Thrombolytic success	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
Successful Surgery	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	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	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	All cause in-hospital mortality.

Trial Locations

Locations (1)

Kosuyolu Kartal Heart Training and Research Hospital; 🇹🇷 İstanbul, Turkey