NCT04330170

Brief Summary

In this study a retrospective analysis of patients database was performed, who underwent treatment for deep vein thrombosis in tertiary hospital by using inferior vena cava-filters

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

4.2 years

First QC Date

March 30, 2020

Last Update Submit

April 2, 2020

Conditions

Deep Vein Thrombosis, Pulmonary Embolus

Keywords

deep vein thrombosisinferior vena cava-filterpulmonary embolism

Outcome Measures

Primary Outcomes (1)

  • Number of participants with occlusion of inferior vena cava-filter

    Number of participants with embolic or thrombotic occlusion of inferior vena cava-filter

    from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks

Secondary Outcomes (2)

  • Number of participants who have undergone cava-filter removal

    from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks

  • Number of participants with implanted cava filter in whom the filter remained intact

    from date of inferior vena cava-filter implantation until the date of discharge, up to 1-2 weeks

Eligibility Criteria

Age16 Years - 91 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

2399 patients who were either hospitalized with venous thromboembolism or diagnosed with venous thromboembolism during hospital stay in 2016-2017. Of them there were 1173 male (48,9%) and 1226 female (51,1%) patients with average age of 62,4 ± 15,2 (min - 16, max - 96).

You may qualify if:

  • Anticoagulation therapy contraindicated
  • Anticoagulation therapy ineffective
  • High pulmonary embolism risk (floating thrombus in proximal location)
  • Deep vein thrombosis/pulmonary embolism together with high pulmonary hypertension(\>50 mm.Hg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Pirogov RNRMU, Zolotukhin Igor Anatolievich

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

January 13, 2016

Primary Completion

March 28, 2020

Study Completion

March 28, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)