NCT06683157 Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance
| NCT ID | NCT06683157 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stadtisches Klinikum Dresden |
| Condition | Acute Embolism and Thrombosis of Calf Muscular Vein |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2017-09-18 |
| Primary Completion | 2024-11-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2017-09-18 with a primary completion date of 2024-11-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The treatment of ICVT is still controversial as conflicting international guideline strategies show. Evidence suggests that propagation rates of ICVT without risk factors are low. Unless ICVT propagates to proximal veins anticoagulation can safely been withheld, thereby avoiding a bleeding risk for the patient. However, the impact of different risk factors on propagation rates is not well understood. This gap in knowledge can only be filled by a natural history study of ICVT without anticoagulation. Since patients are safe as long as no propagation occurs close ultrasound surveillance is an adequate safety umbrella for the natural history study period. In addition, it provides an objective outcome measure to define the impact of risk factors.
Eligibility Criteria
Inclusion Criteria: * Presence of symptomatic ICVT proven by CCUS * Absence of proximal DVT or PE * Age of 18 or older * Outpatient and inpatient status * Written informed consent Exclusion Criteria: * Bedridden patients * Prior unprovoked VTE * Active malignancy (diagnosis within the last 6 months, and/or incomplete resection, and/or ongoing radiotherapy or chemotherapy, and/or metastatic disease). * Pregnancy * Therapeutic anticoagulation therapy for reasons other than VTE
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06683157 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Embolism and Thrombosis of Calf Muscular Vein. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06683157 currently recruiting?
Yes, NCT06683157 is actively recruiting participants. Contact the research team at sebastian.schellong@klinikum-dresden.de for enrollment information.
Where is the NCT06683157 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT06683157 clinical trial?
NCT06683157 is sponsored by Stadtisches Klinikum Dresden. The trial plans to enroll 250 participants.