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

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.

Study Overview

• Status: Unknown
• Conditions: Venous Thromboembolism; Anticoagulants and Bleeding Disorders; Foot Ankle Injuries
• Intervention / Treatment: Drug: Apixaban Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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.

Exclusion Criteria:

• 1)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.

  5) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Apixaban Oral Tablet; Apixaban is a kind of oral anticoagulant drugs used to prevent venous thromboembolism
Experimental: Apixaban	Drug: Apixaban Oral Tablet; Apixaban is a kind of oral anticoagulant drugs used to prevent venous thromboembolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: SAHZJU, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Hemostatic Disorders; Blood Coagulation Disorders; Thromboembolism; Venous Thromboembolism; Ankle Injuries; Ankle Fractures; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: 2019-CPAFVTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No