CompletedNot Applicable

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

Turkey (Türkiye)182 participantsStarted 1993-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Thrombolytic success

Timeframe: 24 hours

Non-fatal complication rates

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

In-hospital mortality

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Trial details

NCT IDNCT01451320

SponsorKartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Prosthetic Valve Thrombosis trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Thrombolytic success

Timeframe: 24 hours

Non-fatal complication rates

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

In-hospital mortality

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 weeks