Incidence of Venous Thromboembolism in Patients With Pelvic and Acetabular Fractures (PAF) (NCT07165587) | Clinical Trial Compass
CompletedNot Applicable
Incidence of Venous Thromboembolism in Patients With Pelvic and Acetabular Fractures (PAF)
Germany81 participantsStarted 2024-01-01
Plain-language summary
The goal of this observational study is to investigate the incidence of venous thromboembolism (VTE) in patients with pelvic and acetabular fractures (PAF). The main question it aims to answer is:
What is the incidence of VTE in PAF patients receiving standardized thromboprophylaxis with enoxaparin 4,000 IU twice daily?
Participants admitted with a pelvic, acetabular, or combined fracture receive thromboprophylaxis as part of their routine clinical care. All participants undergo bilateral duplex ultrasound screening during hospitalization to detect both symptomatic and asymptomatic deep vein thrombosis. If pulmonary embolism is clinically suspected, computed tomography pulmonary angiography is performed.
The study aims to provide prospective observational data on VTE incidence and its association with fracture type, patient risk profile, and treatment modality.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults ≥18 years
* Patients admitted with pelvic ring, acetabular, or combined pelvic-acetabular fracture
* Received thromboprophylaxis with enoxaparin 4,000 IU twice daily
* Hospital admission within the screening period
* Informed consent
Exclusion Criteria:
* Pathological fractures
* Thrombophilia
* Pre-existing oral anticoagulation
* Dementia
* Thromboprophylaxis other than enoxaparin 4,000 IU twice daily
* Admission outside the screening period
* Lack of informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of venous thromboembolism (VTE) during hospital stay
Timeframe: Conservative: 48h, days 3-6 post-trauma. Operative: ≤48h post-trauma, postop days 2-5. Baseline only if admitted ≤48h. Additional exams if clinical suspicion of VTE during hospitalization.
Trial details
NCT IDNCT07165587
SponsorDepartment of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu