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Completed

NCT Number: NCT06877052

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

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.

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Foshan, Guangdong, 528051, China

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. WBC (White Blood Cell count)

    Time frame: From January 2024 to December 2024

    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.

  2. PLT (Platelet count)

    Time frame: From January 2024 to December 2024

    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.

  3. ANC (Absolute Neutrophil Count)

    Time frame: From January 2024 to December 2024

    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.

  4. Lymphocyte count

    Time frame: From January 2024 to December 2024

    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.

  5. Activated Partial Thromboplastin Time (aPTT)

    Time frame: From January 2024 to December 2024

    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.

  6. Fibrinogen

    Time frame: From January 2024 to December 2024

    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.

  7. Thrombin Time

    Time frame: From January 2024 to December 2024

    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.

  8. International Normalized Ratio (INR)

    Time frame: From January 2024 to December 2024

    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.

Sponsors and collaborators

Lead sponsor

Foshan Hospital of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2025
Registry last updated
Mar 14, 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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