Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2026-03-06 @ 8:58 AM
Study NCT ID:
NCT03041805
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caprini Score in Venous Surgery: a Prospective Cohort Study
Sponsor:
Pirogov Russian National Research Medical University
Organization:
Study Overview
Official Title:
A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPSIVS
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: