Acetabular Fractures, Pelvic Fractures, Pelvic Trauma, Pulmonary Embolism and Thrombosis, Thromboprophylaxis, Venous Thromboembolic Event, Venous Thromboembolism
Conditions
Keywords
observational study, pelvic fracuture, acetabular fracture, thromboprophylaxis, venous thromboembolic event
Brief 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.
Detailed description
Pelvic and acetabular fractures (PAF) are serious injuries that carry a high risk of complications, including venous thromboembolism (VTE). VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the most relevant and potentially life-threatening events in trauma patients. While VTE incidence in PAF patients has been reported to range widely in the literature, prospective data with standardized screening and prophylaxis are scarce. This prospective observational cohort study investigates the incidence of VTE in adult patients admitted with pelvic, acetabular, or combined fractures. All participants receive standardized thromboprophylaxis with enoxaparin 4,000 IU administered twice daily, according to institutional protocol. In addition to routine clinical management, bilateral duplex ultrasonography is systematically performed during hospitalization to detect both symptomatic and asymptomatic DVT. In cases where pulmonary embolism is clinically suspected, computed tomography pulmonary angiography is carried out. The primary outcome of the study is the incidence of VTE during the index hospital stay. Secondary outcomes include bleeding complications, and the association of fracture type, patient risk profile, and treatment modality with the occurrence of VTE. The study is designed to provide high-quality observational data that will contribute to the understanding of VTE risk in this vulnerable patient population and may help inform future guidelines on thromboprophylaxis in pelvic and acetabular fracture care.
Interventions
DIAGNOSTIC_TESTBilateral duplex ultrasonography
Bilateral duplex ultrasound screening performed during hospitalization to detect symptomatic and asymptomatic deep vein thrombosis in patients with pelvic and acetabular fractures.
Sponsors
Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of venous thromboembolism (VTE) during hospital stay | 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. | Detection of symptomatic and asymptomatic VTE (deep vein thrombosis or pulmonary embolism) during index hospitalization, assessed by routine duplex ultrasound and clinical imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding complications | From admission until hospital discharge (up to 60 days); bleeding events were continuously monitored throughout the entire index hospitalization. | Number of bleeding events related to thromboprophylaxis |
| Association of VTE with fracture type and treatment modality | VTE assessed during index hospitalization: conservative patients at 48h and days 3-6 post-trauma; operative patients at ≤48h post-trauma and postop days 2-5; additional exams if clinical suspicion, until discharge (up to 60 days). | Exploratory analysis of VTE incidence according to pelvic vs. acetabular vs. combined fractures and operative vs. non-operative treatment. |
Countries
Germany
Outcome results
None listed