A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE)

NCT04128254 | Unknown Phase 4

• 1 other identifier: 2019-CPAFVTE
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Deep vein Thrombosis (Deep Venous Thrombosis, DVT) and Pulmonary Embolism, Pulmonary Embolism, PE) both collectively known as Venous thromboembolism (VTE) (Venous Thrombus Embolism, VTE), is a common clinical disease, and tremendous harmful. Ankle fractures in patients requiring long-term bed braking, increase the incidence of lower extremity deep vein thrombosis, anticoagulant therapy as an important measures to prevent thrombosis in clinical widely accepted, however, the literature anticoagulation effect incision healing. Whether to strike a balance between the two, to develop a foot fracture in accordance with the Chinese characteristics of anticoagulant solution is we try to solve the problem. The purpose of this study is aimed at the use of oral anticoagulants and physical anticoagulant treatment knee far foot fracture patients randomized controlled studies in China.

Conditions

Foot Ankle Injuries; Anticoagulants and Bleeding Disorders; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• the rate of venous thromboembolism (VTE) on 12th postoperative week

  For individual subjects, if after 12 weeks to satisfy all of the following conditions, is considered an effective means to test: 1. The local infection, wound dehiscence, bleeding and swelling, local no abnormal activities; 2. Confirmed by doppler ultrasound has no lower limb venous thromboembolism (VTE); 3. No serious adverse events.

  12th postoperative week

Study Arms (2)

Apixaban

EXPERIMENTAL

Drug: Apixaban Oral Tablet

Placebo

PLACEBO COMPARATOR

Drug: Apixaban Oral Tablet

Interventions

Apixaban Oral Tablet DRUG

Apixaban is a kind of oral anticoagulant drugs used to prevent venous thromboembolism

Apixaban; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) year full 18 one full year of life (2) one side of ankle fractures, calcaneal fractures, the metatarsal bone fracutures will use the internal fixation treatment 3) participants must be able to normal conversation, and understand the problems in the "subject subjective questionnaire", and could provide feedback using the appropriate language.

You may not qualify if:

• )Subjects did not provide a voluntary agreement 2) subjects participating in clinical research for pregnant or lactating women 3) has preoperative examination in the diagnosis of venous thromboembolism (VTE) 4) in patients with preoperative oral antiplatelet/anticoagulation drugs for a long time.
• \) surgery time fractures occur over time more than 3 weeks 6) patients exist pilon fractures (AO type 43-43 - B and C) and ankle multiple fractures, 7) pathological fractures (e.g., primary or metastatic tumors) 8) severe soft tissue injuries, open fractures or vascular injury or the combining bone fascia room syndrome; 9) multiple injuries, judge doesn't fit into the study by researchers, and other parts of the three or more than fracture 10) revision surgery (e.g., malunion, bone nonunion or infection) 11) merger of anticoagulant taboo disease, judge doesn't fit into the study by researchers, such as the active bleeding and clotting disorders, severe head trauma or acute spinal cord injury, platelet count \< 20 ╳ 109 / L, etc.; 12) patients with anesthesia and surgery patients with contraindications to 13) on pp shaaban drug allergy 14) patients may be poor compliance, the researchers determined doesn't fit into the daily (such as excessive drinking or smoking, taking drugs) 15) patients in the past three months participated in other clinical trials; 16) in patients with poor compliance, judge not according to the study by the researchers plan to complete the test, such as schizophrenia and dementia

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Hemostatic Disorders; Venous Thromboembolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thromboembolism; Embolism and Thrombosis

Study Officials

• SAHZJU

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Lu HUANG, Doctor

CONTACT

15158889100; huang_lu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: November 19, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)