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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06877052
Enrollment
429
Registered
2025-03-14
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures

Brief 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. 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.

Interventions

None listed

Sponsors

Foshan Hospital of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* (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. (3) 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. (4) 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. (5) Patients with diabetes, hypertension and other comorbidities should be recorded, because these diseases may affect the occurrence of venous thrombosis.

Exclusion criteria

* (1) Patients with non-fracture types such as upper limb fracture and spinal fracture are not included. (2) Acute patients with symptoms of venous thrombosis such as deep vein thrombosis or pulmonary embolism, or patients with a history of significant thrombosis. (3) Patients whose clinical data or laboratory data are incomplete, resulting in no effective analysis. (4) Patients currently participating in other clinical trials or interventions. (5) Fracture patients who did not receive surgical treatment or only received conservative treatment.

Design outcomes

Primary

MeasureTime frameDescription
WBC (White Blood Cell count)From January 2024 to December 2024WBC (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.
PLT (Platelet count)From January 2024 to December 2024PLT (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.
ANC (Absolute Neutrophil Count)From January 2024 to December 2024ANC (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.
Lymphocyte countFrom January 2024 to December 2024Lymphocyte 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.
Activated Partial Thromboplastin Time (aPTT)From January 2024 to December 2024Activated 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.
FibrinogenFrom January 2024 to December 2024Fibrinogen, 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.
Thrombin TimeFrom January 2024 to December 2024Thrombin 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.
International Normalized Ratio (INR)From January 2024 to December 2024International 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026