Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis

Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Thrombus
• Intervention / Treatment: Drug: Thrombolytic Therapy; Procedure: Surgery

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34844
    • Recruiting
    • Kosuyolu Kartal Heart Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obstructive prosthetic valve thrombosis

Exclusion Criteria:

• Non-obstructive prosthetic valve thrombosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombolytic success	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	Up to 10 days
Non-fatal complications for thrombolytic therapy	Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion. Nonfatal minor complication: Bleeding without need for transfusion, TIA.	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Successful Surgery	Successful redo valve surgery in the absence of fatal and non fatal major complications.	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months
Complications for surgery	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	Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month
In hospital mortality	All cause in-hospital mortality.	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

• Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimate): September 18, 2014

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Surgery; Thrombolytic therapy; Thrombosis; Prosthetic valve; Transesophageal echocardiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents
• Other Study ID Numbers: KOSUYOLU3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No