Mechanical Thrombectomy and Catheter Directed Thrombolysis Utilization in Patients With Deep Vein Thrombosis

June 16, 2024 updated by: Igor Zolotukhin, Pirogov Russian National Research Medical University

The goal of this observational study is to assess the utilization of mechanical thrombectomy and catheter-directed thrombolysis in patients with deep vein thrombosis in tertiary care. The main questions it aims to answer are:

  1. How many patients with deep vein thrombosis are potentially eligible for mechanical thrombectomy and catheter-directed thrombolysis in a tertiary hospital?
  2. What is the actual number of patients undergoing endovascular interventions for deep vein thrombosis?

Participants received endovascular treatment according to the clinical protocol of the treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

Tertiary hospital database was analyzed. All the records of patients referred for deep vein thrombosis were extracted. The collected data included general patient information, medical history, results of physical examination, duplex ultrasound, laboratory analysis, etc. Indications and contraindications for mechanical thrombectomy and catheter-directed thrombolysis were assessed, considering possible benefits and risks. Patients who could be eligible for this technique were identified

Study Type

Observational

Enrollment (Actual)

2427

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with deep vein thrombosis referred to the hospital from January 2022 to December 2023.

Description

Inclusion Criteria:

  • lower limb, pelvic, or inferior vena cava deep vein thrombosis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with deep vein thrombosis who could be eligible for mechanical thrombectomy and catheter-directed thrombolysis
Time Frame: from date of admission until the date of discharge, up to 1-2 weeks
The number of participants with deep vein thrombosis who would fit the eligibility criteria for performing the intervention
from date of admission until the date of discharge, up to 1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with deep vein thrombosis who underwent mechanical thrombectomy and catheter-directed thrombolysis
Time Frame: from date of admission until the date of discharge, up to 1-2 weeks
The number of participants with deep vein thrombosis who fitted the eligibility criteria and underwent the intervention.
from date of admission until the date of discharge, up to 1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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