Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis (TROIA)

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status: Completed

Conditions: Prosthetic Valve Thrombosis

Treatments: Drug: Tissue Plasminogen Activator; Drug: Tissue plasminogen activator; Drug: Streptokinase

Study type: Interventional

Funder types: Other

Identifiers

NCT01451320

11

Details and patient eligibility

About

Despite high mortality and morbidity, the best treatment strategies for prosthetic valve thrombosis (PVT) have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different thrombolytic strategies.Transesophageal echocardiography (TEE) guided thrombolytic treatment was administered to 182 consecutive patients with PVT in 220 different episodes (156 women, mean age 43.2±13.06 years) between 1993 and 2009. These regimens included rapid streptokinase (Group I, 16 episodes), slow streptokinase (Group II, 41 episodes), high dose (100 mg) tissue plasminogen activator (t-PA) (Group III, 12 episodes), half-dose (50 mg) slow infusion (6-hours) of t-PA without bolus (Group IV, 27 episodes), and low dose (25 mg) and slow infusion (6-hours) of t-PA without bolus (Group V, 124 episodes). The study endpoints were thrombolytic success and in-hospital mortality and non-fatal complication rates.

Full description

One hundred and eighty two consecutive in-hospital patients with 220 episodes of PVT between 1993 and 2009 were included in the study. The patients were enrolled after informed consent if there was no contraindication, to thrombolysis. The study was approved by the local Ethics Board. The patient demographics, past medical history, date of the operation, type and make of the prosthetic valve, rhythm disorders, aspirin use, NYHA functional capacity, leading symptoms and international normalization ratio (INR) values at the time of admission were prospectively entered into a database.The diagnosis of PVT was verified each time by transesophageal echocardiography (TEE) when a patient was admitted with thromboembolism or persistently low INR for the preceding consecutive 3 months and when a transthoracic echocardiography (TTE) documented prosthetic valve dysfunction or thrombus. All patients underwent TTE and TEE examination before and after the thrombolysis sessions. The cross sectional area and the longest diameter of the thrombus were measured on TEE recordings

Enrollment: 182 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with prosthetic valve thrombosis

Exclusion criteria

• Large left atrial thrombus
• Recent (<3 weeks) ischemic stroke
• Hemorrhagic stroke
• Early (<4 days) postoperative period
• Traumatic accident <4 weeks
• Bleeding diathesis †
• İntracranial mass
• Active internal bleed
• Aortic dissection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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182 participants in 5 patient groups

rapid streptokinase

Active Comparator group

Description:

3-hour infusion of 1.5 million units of streptokinase (16 patients, 16 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units).

Treatment:

Drug: Streptokinase

Drug: Streptokinase

high dose tpa

Active Comparator group

Description:

5-hour infusion of 90 mg t-PA(Tissue plasminogen activator) after 10 mg bolus (10 patients, 12 episodes), repeat once 24 hours later if needed (maximum total dose 200 mg)

Treatment:

Drug: Tissue plasminogen activator

slow streptokinase

Active Comparator group

Description:

24-hour infusion of 1.5 million units of streptokinase (41 patients, 41 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units).

Treatment:

Drug: Streptokinase

Drug: Streptokinase

half-dose slow infusion tpa

Active Comparator group

Description:

6-hour infusion of 50 mg t-PA (Tissue plasminogen activator) without bolus (27 patients, 27 episodes), repeat once 24 hours later up to 3 times if needed (maximum total dose 150 mg).

Treatment:

Drug: Tissue Plasminogen Activator

Drug: Tissue Plasminogen Activator

low dose slow infusion tpa

Active Comparator group

Description:

6-hour infusion of 25 mg t-PA(Tissue plasminogen activator) without bolus (108 patients, 124 episodes), repeat once 24 hours later up to 6 times if needed (maximum total dose 150 mg).

Treatment:

Drug: Tissue Plasminogen Activator

Drug: Tissue Plasminogen Activator