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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEHMET OZKAN, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT01451320
First received: September 29, 2011
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Prosthetic Valve Thrombosis
Drug: Streptokinase
Drug: Tissue plasminogen activator
Drug: Tissue Plasminogen Activator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis

Resource links provided by NLM:


Further study details as provided by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital:

Primary Outcome Measures:
  • Thrombolytic success [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    • 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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    All cause in-hospital mortality.


Enrollment: 182
Study Start Date: January 1993
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rapid 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).
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 Name: Streptase
Active Comparator: high dose tpa
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)
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 Name: ACTILYSE
Active Comparator: slow 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).
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 Name: Streptase
Active Comparator: half-dose slow infusion tpa
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).
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 Name: ACTILYSE
Active Comparator: low dose slow infusion tpa
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).
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 Name: ACTILYSE

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451320

Locations
Turkey
Kosuyolu Kartal Heart Training and Research Hospital
Istanbul, Turkey, 34844
Sponsors and Collaborators
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Investigators
Principal Investigator: Mehmet Ozkan, Assoc.Prof. Kosuyolu Kartal Heart Training and Research Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MEHMET OZKAN, Principal Investigator, MD., FESC., Assoc. Prof,. Head of Cardiology, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01451320     History of Changes
Other Study ID Numbers: 11
Study First Received: September 29, 2011
Last Updated: October 11, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital:
Prosthetic valve
thrombosis
TROIA
tPA
TEE

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Plasminogen
Tissue Plasminogen Activator
Streptokinase
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 29, 2014