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

Not Applicable

Completed

• Conditions: Prosthetic Valve Thrombosis
• Interventions: Drug: Tissue Plasminogen Activator; Drug: Streptokinase

• Registration Number: NCT01451320
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 1993-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2011-09-29
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-11
• Last Update Submitted: 2011-10-11
• Study First Posted: 2011-10-13
• Last Update Posted: 2011-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
low dose slow infusion tpa	Tissue Plasminogen Activator	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).
half-dose slow infusion tpa	Tissue Plasminogen Activator	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).
rapid streptokinase	Streptokinase	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).
slow streptokinase	Streptokinase	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).
high dose tpa	Tissue Plasminogen Activator	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)

Primary Outcome Measures

Name	Time	Method
Thrombolytic success	24 hours	In the absence of fatal or nonfatal major complications; * Obstructive thrombus: 1. Doppler documentation of the resolution of increased gradient and decreased valve area.; 2. Clinical improvement in symptoms.; 3. 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: 1. Complete success: ≥75% reduction in thrombus area.; 2. Partial success: 50%-75% reduction in thrombus area.
Non-fatal complication rates	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.
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; 🇹🇷 Istanbul, Turkey