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

Prosthetic Valve Thrombosis Clinical Trial

— TROIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451320
• Other study ID #: 11
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: October 11, 2011
• Start date: January 1993
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 †

• Intracranial mass

• Active internal bleed

• Aortic dissection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prosthetic Valve Thrombosis
• Thrombosis

Intervention

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)
• 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).
• 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)
• 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).
• 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).

Locations

Country	Name	City	State
Turkey	Kosuyolu Kartal Heart Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ozkan M, Kaymaz C, Kirma C, Sönmez K, Ozdemir N, Balkanay M, Yakut C, Deligönül U. Intravenous thrombolytic treatment of mechanical prosthetic valve thrombosis: a study using serial transesophageal echocardiography. J Am Coll Cardiol. 2000 Jun;35(7):1881-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombolytic success	In the absence of fatal or nonfatal major complications; Obstructive thrombus: Doppler documentation of the resolution of increased gradient and decreased valve area.; Clinical improvement in symptoms.; 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: Complete success: =75% reduction in thrombus area.; Partial success: 50%-75% reduction in thrombus area.	24 hours	Yes
Primary	Non-fatal complication rates	Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion.; Nonfatal minor complication: Bleeding without need for transfusion, TIA.	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	Yes
Primary	In-hospital mortality	All cause in-hospital mortality.	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	Yes