An interventional study of no intervention in Post Thrombotic Syndrome, Deep Vein Thrombosis and Chronic Thromboembolic Pulmonary Hypertension, sponsored by University Hospital, Montpellier. Completed at 11 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other
Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.
HOKUSAI VTE trial was a randomised double blind non inferiority trial that compared the efficacy and safety of heparin ) (enoxaparin or unfractionated heparin) followed by edoxaban with heparin (enoxaparin or unfractionated heparin) followed by warfarin (target INR 2-3) in patients with acute, symptomatic VTE.
Centers that participated in the HOKUSAI VTE trial will be invited to collect follow of previously enrolled patients at least 2 years after the index VTE.
patients with index DVT will be asked to complete the SF-36 and PembQoL questionnaire to assess the (venous disease-specific) quality of life.
The Villalta score will be used to assess PTS. The objectively and subjectively obtained Villalta score- known as the patient reported Villalta -will be compared .
Among patients with with an index PE, the QoL will be assessed bu the validated generic (SF-36) and DVT at index will be examined for PTS and will be asked to complete all questionnaire.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 156 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients with history of PE (pulmonary embolism) with acute DVT (deep veinous thrombosis) treated with heparin plus edoxaban or heparin plus warfarin
Other: no intervention
SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
cumulative incidence of PTS in patients with an acute DVT
PTS is defined by a Villalta index \>5 or the presence of venous ulcer
Time frame: 2 years
PE related quality of life
questionnaire SF 36
Time frame: 2 years after the index PE
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier