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Ongoing Registry of Treatment of Venous Thromboembolism (RRT VTE)

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ClinicalTrials.gov Identifier: NCT03881345
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Information provided by (Responsible Party):
Evgeny Ilyukhin, Medalp Private Surgery Clinic

Brief Summary:
Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.

Condition or disease Intervention/treatment
Deep Vein Thrombosis Thromboses, Venous Thrombosis Embolism Postthrombotic Syndrome Pulmonary Embolism Drug: Anticoagulants Procedure: Open surgery Procedure: Thrombolysis Procedure: Venous stenting

Detailed Description:

Data of patients with VTE treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.

There is planned to conduct prospective randomized, cohort and observational studies on the site of register


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Russian Registry of Treatment of Venous Thromboembolism
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 1, 2036
Estimated Study Completion Date : March 1, 2036

Intervention Details:
  • Drug: Anticoagulants
    anticoagulation according to the main diagnosis
  • Procedure: Open surgery
    removal of blood clots with open surgery
  • Procedure: Thrombolysis
    removal of blood clots with thrombolysis
  • Procedure: Venous stenting
    elimination of vein obstruction by stenting


Primary Outcome Measures :
  1. Veins patency [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    Change in patency target veins assessed by duplex ultrasonography in different follow up periods due to different treatment methods


Secondary Outcome Measures :
  1. Postthrombotic syndrome [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    the presence and severity of postthrombotic syndrome on the Villalta scale

  2. QoL SF-36 [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    Change in Quality of Life (QoL), assessed by "Short form 36" health survey (SF-36). Total scale range: from 0 to 800. SF-36 consists of 8 subscales. Each subscale range: 0 - 100. Subscales are combined using a special algorithm described in the instructions for the SF-36. For total scale the higher value represent the worse QoL.

  3. QoL AVVQ [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    Change in Quality of Life (QoL), assessed by "Aberdeen Varicose Vein Questionnaire" (AVVQ). The AVVQ is a disease-specific QoL questionnaire aimed at venous disease. Total scale range: from 0 to 100, where the higher score represent worse QoL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing any kind of treatment for venous thromboembolism
Criteria

Inclusion Criteria:

  • case of venous thrombosis of a limb or pulmonary embolus

Exclusion Criteria:

  • no exclusion criteria

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): NCT03881345


Contacts
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Contact: Evgeny Ilyukhin +79218451722 evgeny@ilyukhin.info

Locations
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Russian Federation
Pirogov Russian National Research Medical University Recruiting
Moscow, Russian Federation, 190000
Contact: Yury Stoyko, MD, PhD         
Sponsors and Collaborators
Medalp Private Surgery Clinic
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Additional Information:
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Responsible Party: Evgeny Ilyukhin, Principal Investigator, Medalp Private Surgery Clinic
ClinicalTrials.gov Identifier: NCT03881345     History of Changes
Other Study ID Numbers: A002
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Anticoagulants