Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2026-03-06 @ 8:58 AM
Study NCT ID:
NCT03041805
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caprini Score in Venous Surgery: a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015911', 'term': 'Sclerotherapy'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-01', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'any episode of VTE', 'timeFrame': '0-4 weeks after procedure', 'description': 'symptomatic or asymptomatic, confirmed by instrumental diagnostics'}], 'secondaryOutcomes': [{'measure': 'symptomatic deep vein thrombosis', 'timeFrame': '0-4 weeks after procedure', 'description': 'symptomatic deep vein thrombosis confirmed by duplex ultrasound'}, {'measure': 'symptomatic pulmonary embolism', 'timeFrame': '0-4 weeks after procedure', 'description': 'symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography'}, {'measure': 'asymtomatic deep vein thrombosis', 'timeFrame': '2-4 weeks after procedure', 'description': 'asymptomatic DVT revealed by duplex ultrasound'}, {'measure': 'endovenous thermal-induced thrombosis', 'timeFrame': '0-4 weeks after procedure', 'description': 'EHIT revealed by duplex ultrasound'}, {'measure': 'major bleeding', 'timeFrame': '0-4 weeks after procedure', 'description': 'Fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in haemoglobin level of 20 g/L or more, or leading to transfusion of two or more units of whole blood or red cells.'}, {'measure': 'clinicaly relevant bleeding', 'timeFrame': '0-4 weeks after procedure', 'description': 'any non-major bleeding need for treatment or intervention'}, {'measure': 'death for any reason', 'timeFrame': '0-4 weeks after procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['venous thromboembolism', 'deep vein thrombosis', 'pulmonary embolism', 'varicose veins', 'surgery', 'endovenous laser treatment', 'radiofrequency ablation', 'ultrasound-guided foam sclerotherapy', 'register', 'anticoagulation'], 'conditions': ['Venous Thromboembolism', 'Varicose Veins']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to make a validation of Caprini score in patients undergoing varicose veins surgery, especially endovascular procedures (endovascular laser treatment - EVLT, radiofrequency ablation - RFA, ultrasound-guided foam sclerotherapy - USFS) and to identify patients with elevated risk of postoperative venous thromboembolism (VTE) who will benefit from prophylactic anticoagulation.', 'detailedDescription': 'A prospective cohort study based on the platform of Ongoing Registry of Treatment of Chronic Venous Diseases (NCT03035747). The study will enrol adult patients undergoing any kind of varicose veins surgery with and without any prophylaxis. The patients should be examined for venous thromboembolic complications during 2-4 weeks after the procedure with mandatory duplex ultrasound.\n\nThe study will provide following information:\n\n* the rate of asymptomatic DVT after varicose veins surgery\n* the rate of symptomatic VTE after varicose veins surgery\n* the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation\n* the ability of Caprini scores to predict VTE after varicose veins surgery\n* identification of patients with high risk of VTE who will benefit from prophylaxis, especially with anticoagulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with varicose veins that undergoing any kind of varicose vein surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* any kind of varicose vein surgery\n* follow up for 4 weeks after the procedure\n* examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound\n\nExclusion Criteria:\n\n\\- lost for follow-up during 4 weeks'}, 'identificationModule': {'nctId': 'NCT03041805', 'acronym': 'CAPSIVS', 'briefTitle': 'Caprini Score in Venous Surgery: a Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Pirogov Russian National Research Medical University'}, 'officialTitle': 'A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery', 'orgStudyIdInfo': {'id': 'CAPSIVS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EVLT', 'type': 'PROCEDURE', 'description': 'Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type'}, {'name': 'RFA', 'type': 'PROCEDURE', 'description': 'Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique'}, {'name': 'USFS', 'type': 'PROCEDURE', 'description': 'Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration'}, {'name': 'HL/stripping', 'type': 'PROCEDURE', 'description': 'High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein'}, {'name': 'Miniphlebectomy', 'type': 'PROCEDURE', 'description': 'Miniphlebectomy of any varicose veins under local, regional or general anaesthesia'}, {'name': 'Sclerotherapy', 'type': 'PROCEDURE', 'description': 'Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration'}, {'name': 'GCS', 'type': 'DEVICE', 'description': 'Graduated compression stockings may be used after procedure by the decision of the doctor'}, {'name': 'LMWH', 'type': 'DRUG', 'description': 'Low-molecular-weight heparin may be used after procedure by the decision of the doctor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '117997', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Kirill Lobastov, PhD', 'role': 'CONTACT', 'email': 'lobastov_kv@hotmail.com', 'phone': '+7-985-211-63-31'}], 'facility': 'Pirogov Russian National Research Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Kirill Lobastov, PhD', 'role': 'CONTACT', 'email': 'lobastov_kv@hotmail.com', 'phone': '+7-985-211-63-31'}], 'overallOfficials': [{'name': 'Kirill Lobastov, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pirogov Russian National Research Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Kirill Lobastov', 'investigatorAffiliation': 'Pirogov Russian National Research Medical University'}}}}