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

NCT ID: NCT07165587

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with pelvic and/or acetabular fractures

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

Bilateral duplex ultrasonography

Intervention Type: DIAGNOSTIC_TEST

Bilateral duplex ultrasound screening performed during hospitalization to detect symptomatic and asymptomatic deep vein thrombosis in patients with pelvic and acetabular fractures.

Interventions

Bilateral duplex ultrasonography

Bilateral duplex ultrasound screening performed during hospitalization to detect symptomatic and asymptomatic deep vein thrombosis in patients with pelvic and acetabular fractures.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Trauma and Reconstructive Surgery

Tübingen, Baden-Wurttemberg, Germany

Countries

Germany

References

Mahmoud SS, Esser M, Jain A. Thromboembolic events in pelvic and acetabulum fractures: a systematic review of the current literature on incidence, screening, and thromboprophylaxis. Int Orthop. 2022 Aug;46(8):1707-1720. doi: 10.1007/s00264-022-05431-z. Epub 2022 May 11.

Reference Type: BACKGROUND

PMID: 35543748 (View on PubMed)

Wang P, Kandemir U, Zhang B, Wang B, Li J, Zhuang Y, Wang H, Zhang H, Liu P, Zhang K. Incidence and Risk Factors of Deep Vein Thrombosis in Patients With Pelvic and Acetabular Fractures. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619845066. doi: 10.1177/1076029619845066.

Reference Type: BACKGROUND

PMID: 31014089 (View on PubMed)

Zhao W, Zhao J, Liu T, Liu Z, Liu L, Zhang Y. Incidence and risk factors of preoperative deep venous thrombosis following pelvic and acetabular fractures: a retrospective case-control study. J Orthop Surg Res. 2022 Feb 5;17(1):77. doi: 10.1186/s13018-022-02972-2.

Reference Type: BACKGROUND

PMID: 35123537 (View on PubMed)

Other Identifiers

PAF-VTE

Identifier Type: -

Identifier Source: org_study_id