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

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 .