Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385353
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-16
Brief Title:
DVT Burden and the Risk of Post-thrombotic Syndrome
Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Organization:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study Overview
Official Title:
Baseline Ultrasound Venous Thrombosis Burden and the Risk of Post-thrombotic Syndrome in Patients With a First Acute Unprovoked Episode of Symptomatic Deep Vein Thrombosis of the Lower Limbs - The DVT-Burden Project -
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DVT-Burden
Brief Summary:
Post-thrombotic syndrome PTS is the most common chronic complication of deep vein thrombosis DVT with major consequences for patient quality of life and cost of management Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity
Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment At present although several prognostic markers and models have been proposed it is still difficult to predict who will develop a PTS or a moderate to severe PTS The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden DVT-Burden as a potential prognostic marker for PTS It therefore seems important to study the association between thrombosis burden and the occurrence of PTS
The Venous Volumetric Index or VVI Ouriel 1999 will be used for quantifying DVT-Burden The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT
This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months
Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment At present although several prognostic markers and models have been proposed it is still difficult to predict who will develop a PTS or a moderate to severe PTS The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden DVT-Burden as a potential prognostic marker for PTS It therefore seems important to study the association between thrombosis burden and the occurrence of PTS
The Venous Volumetric Index or VVI Ouriel 1999 will be used for quantifying DVT-Burden The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT
This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months
Detailed Description:
This is a multicenter prospective cohort study aiming at assessing baseline DVT-Burden and other prognostic factors for predicting the occurrence and the severity of PTS
Patients diagnosed with a first episode of unprovoked DVT of the lower limbs are recruited in offices and departments of vascular medicine They will be informed of the study by their physician If patients agree to take part and meet the eligibility criteria they will be included consecutively in the study after signing an informed consent form
The study will include follow-up visits at one week D72 1 month D305 3 months D905 and 6 months D1805
At each visit the following examinations will be carried out
Assessment of symptoms and clinical signs to evaluate the Villalta score
Venous ultrasound evaluation of the lower limbs by colour Doppler ultrasound CDUS Data collected will be useful to calculate the VVI score planned at the study analysis phase
At the D0 D7 D30 and D90 visits blood samples will be taken for research purposes to assess factors of inflammation coagulation and fibrinolysis
At the D90 and D180 visits the patient will also be asked to complete the VEINES-QOL and SF-36 quality of life questionnaires
The patients participation in the research will end at the end of the D180 visit
Patients diagnosed with a first episode of unprovoked DVT of the lower limbs are recruited in offices and departments of vascular medicine They will be informed of the study by their physician If patients agree to take part and meet the eligibility criteria they will be included consecutively in the study after signing an informed consent form
The study will include follow-up visits at one week D72 1 month D305 3 months D905 and 6 months D1805
At each visit the following examinations will be carried out
Assessment of symptoms and clinical signs to evaluate the Villalta score
Venous ultrasound evaluation of the lower limbs by colour Doppler ultrasound CDUS Data collected will be useful to calculate the VVI score planned at the study analysis phase
At the D0 D7 D30 and D90 visits blood samples will be taken for research purposes to assess factors of inflammation coagulation and fibrinolysis
At the D90 and D180 visits the patient will also be asked to complete the VEINES-QOL and SF-36 quality of life questionnaires
The patients participation in the research will end at the end of the D180 visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02652-43 | OTHER | ID-RCB number | None |