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Recruiting NCT03041805

Caprini Score in Venous Surgery: a Prospective Cohort Study

— Observational Venous Thromboembolism Varicose Veins

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EVLT, RFA, USFS, HL/stripping.
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Varicose Veins. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Interventions

  • 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

Primary outcome measures

  • any episode of VTE [Time frame: 0-4 weeks after procedure]
Secondary outcome measures (7)
  • symptomatic deep vein thrombosis [Time frame: 0-4 weeks after procedure]
  • symptomatic pulmonary embolism [Time frame: 0-4 weeks after procedure]
  • asymtomatic deep vein thrombosis [Time frame: 2-4 weeks after procedure]
  • endovenous thermal-induced thrombosis [Time frame: 0-4 weeks after procedure]
  • major bleeding [Time frame: 0-4 weeks after procedure]
  • clinicaly relevant bleeding [Time frame: 0-4 weeks after procedure]
  • death for any reason [Time frame: 0-4 weeks after procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 1 center
  • Pirogov Russian National Research Medical University — Moscow

Identifiers

NCT: NCT03041805 · CAPSIVS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗