Study on Inferior Vena Cava Thrombosis

Inferior Vena Cava Thrombosis Clinical Trial

— SIVECT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04470986
• Other study ID #: SHEBA-20-7345-OC-CTIL
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inferior Vena Cava Thrombosis
• Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	International Society on Thrombosis and Haemostasis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of venous thromboembolism (VTE) recurrence	Recurrence of any venous thrombosis (not previously diagnosed)	2 Years
Primary	Rate of all cause mortality	Mortality (patient's death) from any cause	2 Years
Primary	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	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
Secondary	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
Secondary	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