Incidence of Venous Thromboembolism in Patients With Pelvic and Acetabular Fractures (PAF) (PAF-VTE)

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu

Status: Completed

Conditions: Acetabular Fractures; Venous Thromboembolism; Venous Thromboembolic Event; Pelvic Fractures; Pelvic Trauma; Pulmonary Embolism and Thrombosis; Thromboprophylaxis

Treatments: Diagnostic Test: Bilateral duplex ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT07165587

PAF-VTE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 1 patient group

Patients with pelvic and/or acetabular fractures

Description:

Adult patients (≥18 years) admitted with pelvic, acetabular, or combined fractures. All participants receive standardized thromboprophylaxis with enoxaparin 4,000 IU twice daily as part of routine clinical care and undergo duplex ultrasound screening during hospitalization

Treatment:

Diagnostic Test: Bilateral duplex ultrasonography