Caprini Score in Venous Surgery: a Prospective Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The study will provide following information: the rate of asymptomatic DVT after varicose veins surgery the rate of symptomatic VTE after varicose veins surgery the rate of thermal-induced thrombosis (EHIT) after endovenous thermal ablation the ability of Caprini scores to predict VTE after varicose veins surgery identification of patients with high risk of VTE who will benefit from prophylaxis, especially with anticoagulation

Official Title
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A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery

Conditions
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Venous Thromboembolism, Varicose Veins

Intervention / Treatment
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* Procedure: EVLT
* Procedure: RFA
* Procedure: USFS
* Procedure: HL/stripping
* Procedure: Miniphlebectomy
* Procedure: Sclerotherapy
* Device: GCS
* Drug: LMWH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years any kind of varicose vein surgery follow up for 4 weeks after the procedure examination for VTE at 2-4 weeks after the procedure, including duplex ultrasound Exclusion Criteria: - lost for follow-up during 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: EVLT|Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type|
|Procedure: RFA|Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique|
|Procedure: USFS|Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration|
|Procedure: HL/stripping|High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein|
|Procedure: Miniphlebectomy|Miniphlebectomy of any varicose veins under local, regional or general anaesthesia|
|Procedure: Sclerotherapy|Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration|
|Device: GCS|Graduated compression stockings may be used after procedure by the decision of the doctor|
|Drug: LMWH|Low-molecular-weight heparin may be used after procedure by the decision of the doctor|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any episode of VTE | symptomatic or asymptomatic, confirmed by instrumental diagnostics | 0-4 weeks after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic deep vein thrombosis | symptomatic deep vein thrombosis confirmed by duplex ultrasound | 0-4 weeks after procedure | 
| symptomatic pulmonary embolism | symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography | 0-4 weeks after procedure | 
| asymtomatic deep vein thrombosis | asymptomatic DVT revealed by duplex ultrasound | 2-4 weeks after procedure | 
| endovenous thermal-induced thrombosis | EHIT revealed by duplex ultrasound | 0-4 weeks after procedure | 
| major bleeding | 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. | 0-4 weeks after procedure | 
| clinicaly relevant bleeding | any non-major bleeding need for treatment or intervention | 0-4 weeks after procedure | 
| death for any reason |  | 0-4 weeks after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose veins, venous thromboembolism, deep vein thrombosis, pulmonary embolism, surgery, endovenous laser treatment, radiofrequency ablation, ultrasound-guided foam sclerotherapy, register, anticoagulation