Clinical trial NCT04470986: Study on Inferior Vena Cava Thrombosis
Official title: International Registry on the Diagnosis and Treatment of Inferior Vena Cava Thrombosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inferior Vena Cava Thrombosis
Keywords: Inferior vena cava (IVC)
Thrombosis
Anticoagulation
Deep vein thrombosis (DVT)
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: International Society on Thrombosis and Haemostasis
First posted: 2020-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rates of venous thromboembolism (VTE) recurrence
timeFrame: 2 Years
measure: Rate of all cause mortality
timeFrame: 2 Years
measure: Rates of major bleeding
timeFrame: 2 Years
Secondary outcomes:
measure: Rates of thrombosis recanalization
timeFrame: 2 Years
measure: Rates of post-thrombotic syndrome (PTS)
timeFrame: 2 Years
measure: Rates of clinically relevant non-major bleeding
timeFrame: 2 Years
Other outcomes:
Locations:
Study officials:
References: