Predictors of Attempted Inferior Vena Cava Filters Retrieval.

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT04846725
• Collaborator: (none)
• Enrollment: 356
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 35.5

Study Details

Study Description

Brief Summary

The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal.

All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolic Disease	Other: Data collection

Study Design

• Study Type: Observational
• Actual Enrollment: 356 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Predictors of Attempted Inferior Vena Cava Filters Retrieval.
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm

Intervention/Treatment

Retrievable Inferior Vena Cava Filters (IVCF) The population study includes patients with a Retrievable Inferior Vena Cava Filters (IVCF) inserted between April 2012 and November 2019. Follow up data is collected up to July 2020.

Other: Data collection; Collect in medical records : Filter's retrieval rate Complications of vena cava filters Predictive factors of attempted inferior vena cava filters retrieval: age, the distance between the patient's home and the hospital, the indication or not given by the therapeutic medicine department, patients referred by external structures, patients whose filter was installed during the medical on-call period, the absence of a written request for filter placement, the presence of active neoplasia at the time of filter placement, a peri-surgical context.

Outcome Measures

Primary Outcome Measures

1. Filter's retrieval rate (%) [Month: 2]

   Collect in medical records.

Secondary Outcome Measures

1. Predictive factors of attempted inferior vena cava filters retrieval [Month: 2]

   Collect in medical records.

2. Adverse event of vena cava filters [Month: 2]

   Collect in medical records.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients who had a cave filter placement at Saint-Etienne Hospital between april 2012 and november 2019.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Sylvain Grange, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT04846725
• Other Study ID Numbers: IRBN372021/CHUSTE
• First Posted: Apr 15, 2021
• Last Update Posted: Apr 15, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: Inferior vena cava filter; inferior vena cava filter retrieval; inferior vena cava filter complications; deep vein thrombosis (DVT); pulmonary embolism; venous thromboembolism event (VTE)
• Additional relevant MeSH terms: Thromboembolism

Study Results

No Results Posted as of Apr 15, 2021