Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 1, 2017
First Posted Date February 3, 2017
Last Update Posted Date January 12, 2021
Actual Study Start Date January 1, 2017
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2017)
any episode of VTE [ Time Frame: 0-4 weeks after procedure ]
symptomatic or asymptomatic, confirmed by instrumental diagnostics
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 1, 2017)
  • symptomatic deep vein thrombosis [ Time Frame: 0-4 weeks after procedure ]
    symptomatic deep vein thrombosis confirmed by duplex ultrasound
  • symptomatic pulmonary embolism [ Time Frame: 0-4 weeks after procedure ]
    symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography
  • asymtomatic deep vein thrombosis [ Time Frame: 2-4 weeks after procedure ]
    asymptomatic DVT revealed by duplex ultrasound
  • endovenous thermal-induced thrombosis [ Time Frame: 0-4 weeks after procedure ]
    EHIT revealed by duplex ultrasound
  • 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.
  • clinicaly relevant bleeding [ Time Frame: 0-4 weeks after procedure ]
    any non-major bleeding need for treatment or intervention
  • death for any reason [ Time Frame: 0-4 weeks after procedure ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Caprini Score in Venous Surgery: a Prospective Cohort Study
Official Title A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Any patient with varicose veins that undergoing any kind of varicose vein surgery.
Condition
  • Venous Thromboembolism
  • Varicose Veins
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 1, 2017)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kirill Lobastov, PhD +7-985-211-63-31 lobastov_kv@hotmail.com
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT03041805
Other Study ID Numbers CAPSIVS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kirill Lobastov, Pirogov Russian National Research Medical University
Study Sponsor Pirogov Russian National Research Medical University
Collaborators Not Provided
Investigators
Study Chair: Kirill Lobastov, PhD Pirogov Russian National Research Medical University
PRS Account Pirogov Russian National Research Medical University
Verification Date January 2021