Inferior Vena Cava ThrombosisSIVECTNCT04470986
Study on Inferior Vena Cava Thrombosis
An observational study of Inferior Vena Cava Thrombosis, run by Sheba Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inferior Vena Cava Thrombosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT
Who may be able to join
- 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.
Who cannot join
- Patients enrolled in interventional studies.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inferior Vena Cava Thrombosis
- Keywords
- Inferior vena cava (IVC), Thrombosis, Anticoagulation, Deep vein thrombosis (DVT)
- Medical subject headings
- Thrombosis, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of venous thromboembolism (VTE) recurrence
Recurrence of any venous thrombosis (not previously diagnosed)
Measured: 2 Years
Rate of all cause mortality
Mortality (patient's death) from any cause
Measured: 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.
Measured: 2 Years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena Cava ThrombosisStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- International Society on Thrombosis and Haemostasis
- Responsible party
- Principal investigator, Dr. Omri Cohen, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470986
- Sponsor's protocol ID
- SHEBA-20-7345-OC-CTIL
- Acronym
- SIVECT
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry on the Diagnosis and Treatment of Inferior Vena Cava Thrombosis
- ClinicalTrials.gov ID
- NCT04470986
- Acronym / sponsor ID
- SIVECT / SHEBA-20-7345-OC-CTIL
- Conditions
- Inferior Vena Cava Thrombosis
- Keywords
- Inferior vena cava (IVC), Thrombosis, Anticoagulation, Deep vein thrombosis (DVT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- International Society on Thrombosis and Haemostasis
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients enrolled in interventional studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rates of venous thromboembolism (VTE) recurrence
Time frame: 2 Years
Recurrence of any venous thrombosis (not previously diagnosed)
Rate of all cause mortality
Time frame: 2 Years
Mortality (patient's death) from any cause
Rates of major bleeding
Time frame: 2 Years
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.
3 secondary outcomes
Rates of thrombosis recanalization
Time frame: 2 Years
Rates of post-thrombotic syndrome (PTS)
Time frame: 2 Years
Rates of clinically relevant non-major bleeding
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inferior Vena Cava Thrombosis, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of venous thromboembolism (VTE) recurrence (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.