Pelvic FracturesPAF-VTENCT07165587
Incidence of Venous Thromboembolism in Patients With Pelvic and Acetabular Fractures (PAF)
An observational study of Pelvic Fractures and Acetabular Fractures, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Fractures, Acetabular Fractures, Pelvic Trauma
- What is being tested?
- Bilateral duplex ultrasonography
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 31 Dec 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Department of Trauma and Reconstructive Surgery
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Venous Thromboembolism in Pelvic Ring and Acetabular Fractures - A Prospective Cohort Study
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?
Read more
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.
Read the 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
- Being tested
- Bilateral duplex ultrasonography
- Keywords
- observational study, pelvic fracuture, acetabular fracture, thromboprophylaxis, venous thromboembolic event
- Medical subject headings
- Hip Fractures, Venous Thromboembolism, Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral duplex ultrasonographyDiagnostic test
Bilateral duplex ultrasound screening performed during hospitalization to detect symptomatic and asymptomatic deep vein thrombosis in patients with pelvic and acetabular fractures.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Bilateral duplex ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Number of bleeding events related to thromboprophylaxis
Measured: 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
Exploratory analysis of VTE incidence according to pelvic vs. acetabular vs. combined fractures and operative vs. non-operative treatment.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165587
- Sponsor's protocol ID
- PAF-VTE
- Acronym
- PAF-VTE
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) underlying the results reported in this study will not be made publicly available due to local data protection regulations. Summary-level results will be shared in publications and upon reasonable request to the corresponding author.
Publications
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.
PubMed 35543748Wang 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.
PubMed 31014089Zhao 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.
PubMed 35123537
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism in Pelvic Ring and Acetabular Fractures - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07165587
- Acronym / sponsor ID
- PAF-VTE / PAF-VTE
- Conditions
- Pelvic Fractures, Acetabular Fractures, Pelvic Trauma, Venous Thromboembolic Event, Venous Thromboembolism, Thromboprophylaxis
- Keywords
- observational study, pelvic fracuture, acetabular fracture, thromboprophylaxis, venous thromboembolic event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik TuUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pelvic and/or acetabular fractures | – | Diagnostic Test: Bilateral duplex ultrasonographyAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Pathological fractures
- Thrombophilia
- Pre-existing oral anticoagulation
- Dementia
- Thromboprophylaxis other than enoxaparin 4,000 IU twice daily
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral duplex ultrasonographyBilateral duplex ultrasound screening performed during hospitalization to detect symptomatic and asymptomatic deep vein thrombosis in patients with pelvic and acetabular fractures. | Diagnostic test | Patients with pelvic and/or acetabular fractures |
Primary outcome
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.
2 secondary outcomes
Bleeding complications
Time frame: 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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 35543748Mahmoud 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.
- Background: PubMed 31014089Wang 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.
- Background: PubMed 35123537Zhao 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.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) underlying the results reported in this study will not be made publicly available due to local data protection regulations. Summary-level results will be shared in publications and upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fractures and Acetabular Fractures, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165587, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.