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

NCT07165587 | Completed

• 1 other identifier: PAF-VTE
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

observational study; pelvic fracuture; acetabular fracture; thromboprophylaxis; venous thromboembolic event

Outcome Measures

Primary Outcomes (1)

• Incidence of venous thromboembolism (VTE) during hospital stay

  Detection of symptomatic and asymptomatic VTE (deep vein thrombosis or pulmonary embolism) during index hospitalization, assessed by routine duplex ultrasound and clinical imaging.

  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.

Secondary Outcomes (2)

• Bleeding complications

  From admission until hospital discharge (up to 60 days); bleeding events were continuously monitored throughout the entire index hospitalization.

• 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).

Study Arms (1)

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

Diagnostic Test: Bilateral duplex ultrasonography

Interventions

Bilateral duplex ultrasonography DIAGNOSTIC_TEST

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

Patients with pelvic and/or acetabular fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) admitted to the BG Trauma Center at the University Hospital Tübingen with acute pelvic, acetabular, or combined pelvic-acetabular fractures. All participants received standardized thromboprophylaxis with enoxaparin 4,000 IU twice daily and underwent systematic duplex ultrasound screening during hospitalization.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Trauma and Reconstructive Surgery

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (3)

• 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.

  PMID: 35543748 BACKGROUND

• 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.

  PMID: 31014089 BACKGROUND

• 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.

  PMID: 35123537 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Venous Thromboembolism; Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 10, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)