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
Abstract
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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Effectiveness of Bisphosphonates and Denosumab on Risk of Vertebral Fractures in Prostate Cancer Patients Under Androgen Deprivation Therapies: A Real-World Prospective Study
- Osteoporosis-related fractures after spinal cord injury: a retrospective study from Brazil
- Serum 25-hydroxyvitamin D, parathyroid hormone, and mortality in older men
- Lack of Association between Vitamin D Insufficiency and Cardiovascular or Fracture Risk: A UK Biobank Study
- Muscle strength and body composition are clinical indicators of osteoporosis
- Incidence of bone protection and associated fragility injuries in patients with proximal femur fractures
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.