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

• ClinicalTrials.gov Identifier: NCT03041805
• Recruitment Status: Recruiting
• First Posted: February 3, 2017
• Last Update Posted: January 12, 2021
• Sponsor: Pirogov Russian National Research Medical University
• 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

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

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

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