Venous ThromboembolismCAPSIVSNCT03041805
Caprini Score in Venous Surgery: a Prospective Cohort Study
An observational study of Venous Thromboembolism and Varicose Veins, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Varicose Veins
- What is being tested?
- EVLT, RFA and USFS
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2017to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with varicose veins that undergoing any kind of varicose vein surgery.
Who may be able to join
- 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
Who cannot join
- lost for follow-up during 4 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Pirogov Russian National Research Medical University
Moscow, 117997
Kirill Lobastov, PhD, +7-985-211-63-31, lobastov_kv@hotmail.com
About this study
Official title: A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
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.
Read the 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
- Conditions
- Venous Thromboembolism, Varicose Veins
- Being tested
- EVLT, RFA, USFS, HL/stripping, Miniphlebectomy
- Keywords
- venous thromboembolism, deep vein thrombosis, pulmonary embolism, varicose veins, surgery, endovenous laser treatment, radiofrequency ablation, ultrasound-guided foam sclerotherapy, register, anticoagulation
- Medical subject headings
- Venous Thromboembolism, Varicose Veins, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLTProcedure or surgery
Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
RFAProcedure or surgery
Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
USFSProcedure or surgery
Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
HL/strippingProcedure or surgery
High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
MiniphlebectomyProcedure or surgery
Miniphlebectomy of any varicose veins under local, regional or general anaesthesia
SclerotherapyProcedure or surgery
Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration
GCSDevice
Graduated compression stockings may be used after procedure by the decision of the doctor
LMWHDrug
Low-molecular-weight heparin may be used after procedure by the decision of the doctor
What is being measured
The primary outcome is the main question the study is designed to answer.
any episode of VTE
symptomatic or asymptomatic, confirmed by instrumental diagnostics
Measured: 0-4 weeks after procedure
Secondary outcomes (7)
symptomatic deep vein thrombosis
symptomatic deep vein thrombosis confirmed by duplex ultrasound
Measured: 0-4 weeks after procedure
symptomatic pulmonary embolism
symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography
Measured: 0-4 weeks after procedure
asymtomatic deep vein thrombosis
asymptomatic DVT revealed by duplex ultrasound
Measured: 2-4 weeks after procedure
endovenous thermal-induced thrombosis
EHIT revealed by duplex ultrasound
Measured: 0-4 weeks after procedure
major bleeding
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.
Measured: 0-4 weeks after procedure
clinicaly relevant bleeding
any non-major bleeding need for treatment or intervention
Measured: 0-4 weeks after procedure
death for any reason
Measured: 0-4 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Lobastov, Pirogov Russian National Research Medical University
- Investigators
- Kirill Lobastov, PhD, Study chair, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041805
- Sponsor's protocol ID
- CAPSIVS
- Acronym
- CAPSIVS
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2017
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Register Study for Validation of Caprini Score in Patients Undergoing Varicose Vein Surgery
- ClinicalTrials.gov ID
- NCT03041805
- Acronym / sponsor ID
- CAPSIVS / CAPSIVS
- Conditions
- Venous Thromboembolism, Varicose Veins
- Keywords
- venous thromboembolism, deep vein thrombosis, pulmonary embolism, varicose veins, surgery, endovenous laser treatment, radiofrequency ablation, ultrasound-guided foam sclerotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with varicose veins that undergoing any kind of varicose vein surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- lost for follow-up during 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVLTEndovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type | Procedure or surgery | – |
| RFARadiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique | Procedure or surgery | – |
| USFSUltrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration | Procedure or surgery | – |
| HL/strippingHigh ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein | Procedure or surgery | – |
| MiniphlebectomyMiniphlebectomy of any varicose veins under local, regional or general anaesthesia | Procedure or surgery | – |
| SclerotherapyFoam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration | Procedure or surgery | – |
| GCSGraduated compression stockings may be used after procedure by the decision of the doctor | Device | – |
| LMWHLow-molecular-weight heparin may be used after procedure by the decision of the doctor | Drug | – |
Primary outcome
any episode of VTE
Time frame: 0-4 weeks after procedure
symptomatic or asymptomatic, confirmed by instrumental diagnostics
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirill Lobastov, PhD study chair
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Varicose Veins, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirill Lobastov, PhD (+7-985-211-63-31, lobastov_kv@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
any episode of VTE (time frame: 0-4 weeks after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.