Upper Extremity Post Thrombotic Syndrome (UE-PTS), post thrombotic syndrome, UE-DVT, Upper Extremity Deep Vein Thrombosis (UE-DVT) arm thrombosis
Conditions
Interventions
UE-PTS score ? score which we developed ourself in previous studies.Ultrasound (duplex) 
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Presence of previous primary UE-DVT diagnosed at least 3 months agoA confirmed UE-DVT is defined as thrombosis visualized on imaging (duplex ultrasound, CT, MRI or angiography) in het subclavian, axillary, brachial, cephalic, and/or basilic vein, together with corresponding clinical signs and symptoms.Aged 18 years and olderAvailability to physically come to the UMC Utrecht for an extra visitSigned informed consentAble to speak and understand Dutch
Exclusion criteria
Exclusion criteria: Absence of confirmed UE-DVTUE-DVT secondary to other pathology (e.g. central venous catheter, pacemaker, malignancy)Known or active malignancy at the time of UE-DVT diagnosis or at the time of study inclusion. Assessment of malignancy is based on routine clinical evaluation; no additional screening procedures are performed as part of this studyUE-DVT diagnosed less than 3 months ago prior to study inclusionIndividuals who are unwilling to sign complete or partial informed consentUnable to speak and understand, read or write Dutch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to assess the construct validity of the UE-PTS score by evaluating its correlation with patient-reported outcomes on quality of life (QoL). To assess QoL, two validated questionnaires will be used: the Short Form-36 Health Survey (SF-36) and the Venous Insufficiency Epidemiological and Economic Study Quality of Life Questionnaire (VEINES-QoL). These instruments will allow for a comprehensive assessment of the impact of UE-PTS on the participants’ daily functioning and overall well-being. | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in the UE-PTS score for the unaffected arm will be assessed as a control.The feasibility of the UE-PTS score will be evaluated by asking the participants to rate their experience after completing the questionnaires. Feasibility will be assessed using a Likert scale (ranging from 1 to 5) on the following aspects: Ease of understanding, Accuracy of symptom reflection, and Overall satisfaction.The inter-rater reliability of the UE-PTS score will be examined by having three different healthcare professionals independently assess each participant at the same time (within the same hour). The three raters will be blinded for each other assessments.Additionally, we will perform a subgroup analysis to investigate the potential impact of an affected dominant arm on both the UE-PTS score and Quality of Life outcomes.We will also explore the difference between the UE-PTS scores of the affected arm and the contralateral (unaffected) arm within this subgroup.The association between the UE-PTS severity score and anatomical abnormalities on duplex ultrasonography will be assessed, specifically the presence or absence of residual venous obstruction and/or residual thrombus, as an objective measure of construct validity. | — |
Countries
Netherlands
Contacts
Public ContactT. Tjep
Universitair Medisch Centrum Utrecht
Outcome results
None listed