Study on Inferior Vena Cava Thrombosis (SIVECT)

International Registry on the Diagnosis and Treatment of Inferior Vena Cava Thrombosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inferior Vena Cava Thrombosis

Detailed Description

Thrombosis of the inferior vena cava (IVC) is a rare form of deep venous thrombosis (DVT). Optimal treatment strategies and clinical outcomes are not well established.

This multicenter, international, observational study will assess the effectiveness and safety of current treatment options in patients with IVC thrombosis, and describe the long-term outcomes of patients with IVC thrombosis.

Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT will be included. Information will be collected on baseline characteristics, risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb DVT, PE, IVC filter or unusual site thrombosis (splanchnic, gonadal and renal veins), treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and duration of treatment, recanalization assessment (if available), recurrence of VTE during follow up, bleeding according to International Society on Thrombosis and Haemostasis criteria, development post-thrombotic syndrome (PTS) according to Villalta score and mortality during follow up. Patients should be followed up for 24 months from diagnosis. The number of visits is left to the discretion of the treating physician, but information on clinical outcomes at two intermediate time points is requested.

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT

Description

Inclusion criteria:

1. 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.
2. Diagnosis should be obtained by either doppler ultrasonography, CT angiography or MRI angiography.
3. 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.

Exclusion criteria:

Patients enrolled in interventional studies.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of thrombosis recanalization	Evidence of thrombosis resolution by imaging (none/partial/complete, with regard to the latest imaging study), with time from initiation of therapy to thrombus resolution being calculated accordingly.	2 Years
Rates of post-thrombotic syndrome (PTS)	According to: Goldenberg NA, Brandão L, Journeycake J, Kahn S, Monagle P et al. Definition of post-thrombotic syndrome following lower extremity deep venous thrombosis and standardization of outcome measurement in pediatric clinical investigations. J Thromb Haemost. 2012 Mar;10(3):477-80.	2 Years
Rates of clinically relevant non-major bleeding	Clinically relevant non-major bleeding per International Society on Thrombosis and Haemostasis criteria Kaatz S, Ahmad D, Spyropoulos AC, Schulman S, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26.	2 Years

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: International Society on Thrombosis and Haemostasis

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Anticoagulation; Thrombosis; Deep vein thrombosis (DVT); Inferior vena cava (IVC)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: SHEBA-20-7345-OC-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No