Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01451320
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2011-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013300', 'term': 'Streptokinase'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-11', 'studyFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2011-10-11', 'lastUpdatePostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thrombolytic success', 'timeFrame': '24 hours', 'description': 'In the absence of fatal or nonfatal major complications;\n\n* Obstructive thrombus:\n\n 1. Doppler documentation of the resolution of increased gradient and decreased valve area.\n 2. Clinical improvement in symptoms.\n 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.\n* Nonobstrucive thrombus:\n\n 1. Complete success: ≥75% reduction in thrombus area.\n 2. Partial success: 50%-75% reduction in thrombus area.'}, {'measure': 'Non-fatal complication rates', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks', 'description': '* Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion.\n* Nonfatal minor complication: Bleeding without need for transfusion, TIA.'}, {'measure': 'In-hospital mortality', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 weeks', 'description': 'All cause in-hospital mortality.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prosthetic valve', 'thrombosis', 'TROIA', 'tPA', 'TEE'], 'conditions': ['Prosthetic Valve Thrombosis']}, 'referencesModule': {'references': [{'pmid': '10841239', 'type': 'BACKGROUND', 'citation': 'Ozkan M, Kaymaz C, Kirma C, Sonmez K, Ozdemir N, Balkanay M, Yakut C, Deligonul 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. doi: 10.1016/s0735-1097(00)00654-9.'}, {'pmid': '23489534', 'type': 'DERIVED', 'citation': 'Ozkan M, Gunduz S, Biteker M, Astarcioglu MA, Cevik C, Kaynak E, Yildiz M, Oguz E, Aykan AC, Erturk E, Karavelioglu Y, Gokdeniz T, Kaya H, Gursoy OM, Cakal B, Karakoyun S, Duran N, Ozdemir N. Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial. JACC Cardiovasc Imaging. 2013 Feb;6(2):206-16. doi: 10.1016/j.jcmg.2012.10.016.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with prosthetic valve thrombosis\n\nExclusion Criteria:\n\n* Large left atrial thrombus\n* Recent (\\<3 weeks) ischemic stroke\n* Hemorrhagic stroke\n* Early (\\<4 days) postoperative period\n* Traumatic accident \\<4 weeks\n* Bleeding diathesis †\n* İntracranial mass\n* Active internal bleed\n* Aortic dissection'}, 'identificationModule': {'nctId': 'NCT01451320', 'acronym': 'TROIA', 'briefTitle': 'Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}, 'officialTitle': 'Comparison of Different TRansesophageal Echocardiography Guided thrOmbolytic Regimens for prosthetIc vAlve Thrombosis', 'orgStudyIdInfo': {'id': '11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rapid streptokinase', 'description': '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).', 'interventionNames': ['Drug: Streptokinase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high dose tpa', 'description': '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)', 'interventionNames': ['Drug: Tissue plasminogen activator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'slow streptokinase', 'description': '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).', 'interventionNames': ['Drug: Streptokinase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'half-dose slow infusion tpa', 'description': '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).', 'interventionNames': ['Drug: Tissue Plasminogen Activator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low dose slow infusion tpa', 'description': '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).', 'interventionNames': ['Drug: Tissue Plasminogen Activator']}], 'interventions': [{'name': 'Streptokinase', 'type': 'DRUG', 'otherNames': ['Streptase'], 'description': '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)', 'armGroupLabels': ['rapid streptokinase']}, {'name': 'Streptokinase', 'type': 'DRUG', 'otherNames': ['Streptase'], 'description': '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).', 'armGroupLabels': ['slow streptokinase']}, {'name': 'Tissue plasminogen activator', 'type': 'DRUG', 'otherNames': ['ACTILYSE'], 'description': '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)', 'armGroupLabels': ['high dose tpa']}, {'name': 'Tissue Plasminogen Activator', 'type': 'DRUG', 'otherNames': ['ACTILYSE'], 'description': '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).', 'armGroupLabels': ['half-dose slow infusion tpa']}, {'name': 'Tissue Plasminogen Activator', 'type': 'DRUG', 'otherNames': ['ACTILYSE'], 'description': '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).', 'armGroupLabels': ['low dose slow infusion tpa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34844', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kosuyolu Kartal Heart Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mehmet Ozkan, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kosuyolu Kartal Heart Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD., FESC., Assoc. Prof,. Head of Cardiology', 'investigatorFullName': 'MEHMET OZKAN', 'investigatorAffiliation': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}}}}