Clinical trial NCT02243839: Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis
Official title: Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Thrombus
Keywords: Prosthetic valve
Thrombosis
Surgery
Thrombolytic therapy
Transesophageal echocardiography
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Obstructive prosthetic valve thrombosis

Exclusion Criteria:

* Non-obstructive prosthetic valve thrombosis

Primary outcomes:
measure: Thrombolytic success
timeFrame: Up to 10 days
measure: Non-fatal complications for thrombolytic therapy
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Successful Surgery
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months
measure: Complications for surgery
timeFrame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month
measure: In hospital mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kosuyolu Kartal Heart Training and Research Hospital
Study officials:
References: