Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01451320
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:
NCT01451320
Study Brief:
Protocol Section:
NCT01451320