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FracturesNCT06877052

Prediction of Venous Thrombosis After Fracture Operation: Comparative Analysis of Different Fracture Sites

An observational study of Fractures, run by Foshan Hospital of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to analyze the clinical characteristics of patients who develop lower limb deep vein thrombosis (DVT) following fracture surgery, with a focus on comparing different fracture sites. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Fractures
How many people
429 participants
Where
1 siteChina
Study dates
1 Jan 2024to 31 Dec 2024
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Demographics and Baseline Characteristics: The study population includes both male and female patients, with a focus on identifying how age, sex, and comorbid conditions may influence the development of DVT. Age ranges from 18 to over 90 years, with a significant portion of the cohort being elderly (over 60 years old), a group known to be at higher risk for thrombotic events. The patient cohort also includes individuals with varying body mass indices (BMIs), preoperative comorbidities (such as diabetes, hypertension, and cardiovascular disease), and different surgical approaches.Data Collection: For each patient, a comprehensive dataset was collected, including demographic information (age, sex, BMI), clinical characteristics (fracture type, comorbidities, type of surgical intervention), thrombus characteristics (size, location, number), and postoperative complications (e.g., the presence of pulmonary embolism). In addition, laboratory parameters, such as D-dimer levels, complete blood

Who may be able to join

  • (1) Age requirement: ≥18 years old, gender is not limited. (2) Including but not limited to rib fracture, femur fracture, tibia and fibula fracture, ankle fracture and other types of fracture (3) Patients with fractures who have undergone surgical treatment and patients with postoperative complications related to venous thrombosis.
  • The patient's clinical data (such as age, gender, fracture type, surgical method, postoperative recovery, etc.) and laboratory data (such as D-dimer, coagulation function, etc.) should be fully available.
  • Informed consent: Patients voluntarily participate in this study, sign informed consent, and promise to cooperate with the completion of the evaluation and follow-up in the study.
  • Patients with diabetes, hypertension and other comorbidities should be recorded, because these diseases may affect the occurrence of venous thrombosis.

Who cannot join

  • (1) Patients with non-fracture types such as upper limb fracture and spinal fracture are not included.
  • Acute patients with symptoms of venous thrombosis such as deep vein thrombosis or pulmonary embolism, or patients with a history of significant thrombosis.
  • Patients whose clinical data or laboratory data are incomplete, resulting in no effective analysis.
  • Patients currently participating in other clinical trials or interventions. (5) Fracture patients who did not receive surgical treatment or only received conservative treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Foshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Foshan, 528051, Guangdong, China.

    Foshan, Guangdong, 528051

Other trials in China

About this study

The goal of this observational study is to analyze the clinical characteristics of patients who develop lower limb deep vein thrombosis (DVT) following fracture surgery, with a focus on comparing different fracture sites. The main question it aims to answer is: How do the clinical characteristics of postoperative DVT vary across different fracture sites? The study will involve 429 patients who have been diagnosed with postoperative lower limb DVT following fracture surgery. Data will be collected on patient demographics, fracture type, surgical approach, thrombus size, number, location, and the occurrence of complications such as pulmonary embolism (PE). Participants will also be evaluated for relevant laboratory markers and clinical factors, including coagulation parameters and inflammatory markers.

By examining how these factors differ across fracture sites and their relationship to thrombus characteristics, this study seeks to better understand the risk factors and clinical course of postoperative DVT in orthopedic patients. The findings will provide valuable insights for improving patient management strategies and reducing the risk of complications such as PE in those undergoing fracture surgery.

Conditions
Fractures
Medical subject headings
Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06877052
Study groupRoleWhat they receive
Upper limb fracture group, lower limb fracture group, trunk fracture group, multiple fracture groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WBC (White Blood Cell count)

    WBC (White Blood Cell count), measured in cells/µL,All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  2. PLT (Platelet count)

    PLT (Platelet count), measured in cells/µL; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  3. ANC (Absolute Neutrophil Count)

    ANC (Absolute Neutrophil Count), measured in cells/µL; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  4. Lymphocyte count

    Lymphocyte count, measured in cells/µL. All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  5. Activated Partial Thromboplastin Time (aPTT)

    Activated Partial Thromboplastin Time (aPTT), measured in seconds; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  6. Fibrinogen

    Fibrinogen, measured in mg/dL; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  7. Thrombin Time

    Thrombin Time, measured in seconds; All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

  8. International Normalized Ratio (INR)

    International Normalized Ratio (INR), measured as a ratio,All these markers will be assessed at baseline (Day 0) and during monthly follow-up visits throughout the study period from January 2024 to December 2024. Data will be collected and summarized as.

    Measured: From January 2024 to December 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start1 Jan 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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
Cross-sectional
Enrolment
429 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877052
Sponsor's protocol ID
FoshanTCM User
Status last verified
Mar 2025
First submitted
8 Mar 2025
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Hu Y, Zhu L, Tian X, Duan F. Prevalence of preoperative deep vein thrombosis in long bone fractures of lower limbs: a systematic review and meta-analysis. J Orthop Traumatol. 2023 May 8;24(1):19. doi: 10.1186/s10195-023-00699-2.

    PubMed 37156964

  • Kobayashi T, Akiyama T, Mawatari M. Predictors of preoperative deep vein thrombosis in hip fractures: A systematic review and meta-analysis. J Orthop Sci. 2023 Jan;28(1):222-232. doi: 10.1016/j.jos.2021.08.013. Epub 2021 Sep 27.

    PubMed 34593286

Questions about this trial

What is this clinical trial studying?

An observational study of Fractures, run by Foshan Hospital of Traditional Chinese Medicine at 1 site in China.

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 4 inclusion and 4 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 14 Mar 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 China. 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?

WBC (White Blood Cell count) (time frame: From January 2024 to December 2024). The study lists 8 primary outcomes in all. 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 NCT06877052, which also lists 2 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 14 Mar 2025.

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