Status:
TERMINATED
Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding
Lead Sponsor:
Leiden University Medical Center
Conditions:
Venous Thromboembolism
Eligibility:
FEMALE
18-50 years
Brief Summary
This study is an international, multicenter, academically sponsored, observational study, that focusses on fertile female patients with proven symptomatic deep vein thrombosis of the legs (DVT) or acu...
Detailed Description
A recently performed international survey of expert opinion and current practice revealed divergent expert recommendations and very heterogeneous management approach in clinical practice with regard t...
Eligibility Criteria
Inclusion
- Ability of subject to understand the character and individual consequences of this clinical study;
- Signed and dated informed consent of the subject available before the start of any specific study procedures;
- Age ≥18 years and ≤ 50 years;
- Confirmed symptomatic first or recurrent VTE;
- DVT: incompressibility of proximal or distal veins of the affected leg by compression ultrasonography or venous filling defect on multi-detector computed tomography venography. The diagnosis of ipsilateral recurrent DVT is defined as a CUS that shows incompressibility of a different venous segment than at the reference CUS examination, or in case of a pronounced increase in vein diameter (≥4 mm) of a previous non-compressible venous segment, or by an abnormal signal of Magnetic resonance direct thrombus imaging (MRDTI);
- PE: both first and recurrent PE are diagnosed in case of at least one filling defect in the pulmonary artery tree on multi-detector computed tomography pulmonary angiography (CTPA) up to the subsegmental level, or high probability result of ventilation perfusion scintigraphy;
- Childbearing potential, i.e. with active menstrual cycle with or without hormonal regulation of any kind initiated for reasons of either contraception or for treatment of abnormal menstrual bleeding;
- Inclusion before the first day of next menstrual cycle after VTE diagnosis or within 1 month after the VTE diagnosis, whichever comes first.
Exclusion
- Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;
- Woman between the ages of 18 and 50 with premature menopause (established before study inclusion);
- Planned treatment with parenteral anticoagulation (and no switch to oral drugs);
- Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 6 months, or unwillingness to sign informed consent;
- Non-compliance or inability to adhere to the follow-up visits;
- Pregnancy or post-partum (first three months) associated VTE;
- Active in vitro fertilization (IVF) treatment or planned IVF treatment during the study period.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04748393
Start Date
September 1 2018
End Date
February 1 2021
Last Update
February 10 2021
Active Locations (7)
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1
Medical University Hospital
Vienna, Austria
2
Hôpital de la Cavale Blanche
Brest, France
3
CHU Saint-Etienne
Saint-Etienne, France
4
University Medical Centre Mannheim
Mannheim, Germany