Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis

Obstructive Thrombus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02243839
• Other study ID #: KOSUYOLU3
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2014
• Last updated: September 16, 2014
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2014
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Obstructive prosthetic valve thrombosis

Exclusion Criteria:

• Non-obstructive prosthetic valve thrombosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Thrombus
• Thrombosis

Intervention

Drug:
• Thrombolytic Therapy
Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis

Procedure:
• Surgery
Redo valve surgery is performed for obstructive valve thrombosis

Locations

Country	Name	City	State
Turkey	Kosuyolu Kartal Heart Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	In hospital mortality	All cause in-hospital mortality.	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	Yes