Study on Inferior Vena Cava Thrombosis
SIVECT
International Registry on the Diagnosis and Treatment of Inferior Vena Cava Thrombosis
1 other identifier
observational
200
0 countries
N/A
Brief Summary
This study will focus on patients having inferior vena cava (IVC) thrombosis, either with or without thrombosis in other veins. The purpose of this study is to assess risk factors, safety and effectiveness of treatment options, and outcomes of patients with IVC thrombosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 22, 2020
October 1, 2020
2.6 years
July 8, 2020
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rates of venous thromboembolism (VTE) recurrence
Recurrence of any venous thrombosis (not previously diagnosed)
2 Years
Rate of all cause mortality
Mortality (patient's death) from any cause
2 Years
Rates of major bleeding
Major bleeding per International Society on Thrombosis and Haemostasis criteria Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692- 4.
2 Years
Secondary Outcomes (3)
Rates of thrombosis recanalization
2 Years
Rates of post-thrombotic syndrome (PTS)
2 Years
Rates of clinically relevant non-major bleeding
2 Years
Eligibility Criteria
Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT
You may qualify if:
- Consecutive adult patients (\> 18 years) with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT (involving the femoral, common femoral, or iliac veins) will be eligible for the study.
- Diagnosis should be obtained by either doppler ultrasonography, CT angiography or MRI angiography.
- Patients who had objective diagnosis of IVC thrombosis within 6 months prior to the starting of the registry will also be eligible, providing they are prospectively followed up by the participating centers and all requested information is available.
You may not qualify if:
- Patients enrolled in interventional studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Unusual site thrombosis service
Study Record Dates
First Submitted
July 8, 2020
First Posted
July 14, 2020
Study Start
June 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
October 22, 2020
Record last verified: 2020-10