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Background <p>Venous thromboembolism (VTE) is a common and potentially fatal complication in orthopedic trauma patients, particularly following lower limb and hip-related fractures. While pharmacological prophylaxis is the cornerstone of prevention for patients at moderate to high risk, its use is a balance between efficacy and bleeding risk. Clinical pharmacists play an increasingly important role in optimizing pharmacotherapy, but evidence for the effectiveness of a comprehensive, pharmacist-led management model spanning both inpatient and outpatient care for VTE prophylaxis in this population is scarce.</p> Methods <p>This is a single-center, prospective, randomized controlled trial. One hundred seventy eligible orthopedic trauma patients at risk for VTE will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a pharmacist-led, full-course management model, which includes personalized VTE risk (Caprini score) and bleeding risk assessment, medication reconciliation, patient education, dosing optimization, adverse event monitoring, and structured follow-up via telephone at 21, 35, and 90&#xa0;days post-discharge. The control group will receive standard medical care without this structured pharmacist intervention. The primary outcome is the incidence of symptomatic and asymptomatic VTE within 90&#xa0;days post-surgery. Secondary outcomes include the incidence of major and clinically relevant non-major bleeding events, medication adherence (measured by Medication Possession Ratio). Data will be analyzed on an intention-to-treat basis.</p> Discussion <p>This randomized controlled trial aims to generate high-quality evidence on the effectiveness of a clinical pharmacist-led management model for improving outcomes in orthopedic trauma patients requiring VTE prophylaxis.</p> Trial registration <p>The study has been registered in the Chinese Clinical Trial Registry (retrospectively registered no. ChiCTR2500107932) on 21 August 2025, at <a href="https://www.chictr.org.cn/showproj?proj=279391">https://www.chictr.org.cn/showproj?proj=279391</a>.</p>

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Development and evaluation of a clinical pharmacist-led full-course management model for venous thromboembolism prophylaxis in orthopedic trauma patients: study protocol for a randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2026年2月10日

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  • Ruping Ni,
  • Ping Huang,
  • Zhaowen Gao,
  • Dongli Lu,
  • Linfang Huang,
  • Huijuan Xie,
  • Zhenghua Jiang,
  • Zhaochun Wu

摘要

Background

Venous thromboembolism (VTE) is a common and potentially fatal complication in orthopedic trauma patients, particularly following lower limb and hip-related fractures. While pharmacological prophylaxis is the cornerstone of prevention for patients at moderate to high risk, its use is a balance between efficacy and bleeding risk. Clinical pharmacists play an increasingly important role in optimizing pharmacotherapy, but evidence for the effectiveness of a comprehensive, pharmacist-led management model spanning both inpatient and outpatient care for VTE prophylaxis in this population is scarce.

Methods

This is a single-center, prospective, randomized controlled trial. One hundred seventy eligible orthopedic trauma patients at risk for VTE will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a pharmacist-led, full-course management model, which includes personalized VTE risk (Caprini score) and bleeding risk assessment, medication reconciliation, patient education, dosing optimization, adverse event monitoring, and structured follow-up via telephone at 21, 35, and 90 days post-discharge. The control group will receive standard medical care without this structured pharmacist intervention. The primary outcome is the incidence of symptomatic and asymptomatic VTE within 90 days post-surgery. Secondary outcomes include the incidence of major and clinically relevant non-major bleeding events, medication adherence (measured by Medication Possession Ratio). Data will be analyzed on an intention-to-treat basis.

Discussion

This randomized controlled trial aims to generate high-quality evidence on the effectiveness of a clinical pharmacist-led management model for improving outcomes in orthopedic trauma patients requiring VTE prophylaxis.

Trial registration

The study has been registered in the Chinese Clinical Trial Registry (retrospectively registered no. ChiCTR2500107932) on 21 August 2025, at https://www.chictr.org.cn/showproj?proj=279391.