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NCT Number: NCT07165587

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

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.

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Key information

Conditions

Pelvic Fractures Acetabular Fractures Cardiovascular Diseases Embolism Embolism and Thrombosis Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Lung Diseases Pelvic Trauma Pulmonary Embolism Pulmonary Embolism and Thrombosis Respiratory Tract Diseases Thromboembolism Thromboprophylaxis Thrombosis Vascular Diseases Venous Thromboembolic Event Venous Thromboembolism Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Trauma and Reconstructive Surgery

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of venous thromboembolism (VTE) during hospital stay

    Time frame: 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 outcomes

  1. Bleeding complications

    Time frame: 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

  2. Association of VTE with fracture type and treatment modality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Venous Thromboembolism in Pelvic Ring and Acetabular Fractures - A Prospective Cohort Study

Acronym: PAF-VTE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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