Trial | NCT01451320  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    streptokinase alteplase ...

  • Study Participants

    182
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.
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 Started
Jan 31
1993
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Oct 13
2011
Estimate

Drug 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)

  • Other names: Streptase

Drug 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).

  • Other names: Streptase

Drug 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)

  • Other names: ACTILYSE

Drug 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).

  • Other names: ACTILYSE

Drug 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).

  • Other names: ACTILYSE

rapid streptokinase Active Comparator

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).

high dose tpa Active Comparator

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)

slow streptokinase Active Comparator

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).

half-dose slow infusion tpa Active Comparator

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).

low dose slow infusion tpa Active Comparator

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).

Criteria 

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
No Results Posted