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Caprini Score in Venous Surgery: a Prospective Cohort Study (CAPSIVS)

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ClinicalTrials.gov Identifier: NCT03041805
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Kirill Lobastov, Pirogov Russian National Research Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Venous Thromboembolism Varicose Veins Procedure: EVLT Procedure: RFA Procedure: USFS Procedure: HL/stripping Procedure: Miniphlebectomy Procedure: Sclerotherapy Device: GCS Drug: LMWH

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
Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. any episode of VTE [ Time Frame: 0-4 weeks after procedure ]
    symptomatic or asymptomatic, confirmed by instrumental diagnostics


Secondary Outcome Measures :
  1. symptomatic deep vein thrombosis [ Time Frame: 0-4 weeks after procedure ]
    symptomatic deep vein thrombosis confirmed by duplex ultrasound

  2. symptomatic pulmonary embolism [ Time Frame: 0-4 weeks after procedure ]
    symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography

  3. asymtomatic deep vein thrombosis [ Time Frame: 2-4 weeks after procedure ]
    asymptomatic DVT revealed by duplex ultrasound

  4. endovenous thermal-induced thrombosis [ Time Frame: 0-4 weeks after procedure ]
    EHIT revealed by duplex ultrasound

  5. major bleeding [ Time Frame: 0-4 weeks after procedure ]
    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.

  6. clinicaly relevant bleeding [ Time Frame: 0-4 weeks after procedure ]
    any non-major bleeding need for treatment or intervention

  7. death for any reason [ Time Frame: 0-4 weeks after procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient with varicose veins that undergoing any kind of varicose vein surgery.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041805


Contacts
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Contact: Kirill Lobastov, PhD +7-985-211-63-31 lobastov_kv@hotmail.com

Locations
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Russian Federation
Pirogov Russian National Research Medical University Recruiting
Moscow, Russian Federation, 117997
Contact: Kirill Lobastov, PhD    +7-985-211-63-31    lobastov_kv@hotmail.com   
Sponsors and Collaborators
Pirogov Russian National Research Medical University
Investigators
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Study Chair: Kirill Lobastov, PhD Pirogov Russian National Research Medical University
More Information
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Responsible Party: Kirill Lobastov, Associated Professor, Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier: NCT03041805    
Other Study ID Numbers: CAPSIVS
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirill Lobastov, Pirogov Russian National Research Medical University:
venous thromboembolism
deep vein thrombosis
pulmonary embolism
varicose veins
surgery
 endovenous laser treatment
radiofrequency ablation
ultrasound-guided foam sclerotherapy
register
anticoagulation
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Varicose Veins
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases