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

NCT ID: NCT06877052

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

429 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Upper limb fracture group, lower limb fracture group, trunk fracture group, multiple fracture group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Qilong Nie

DIRECTOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Foshan, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 37156964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34593286 (View on PubMed)

Other Identifiers

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FoshanTCM User

Identifier Type: -

Identifier Source: org_study_id

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