Clinical Trial

Venous Thromboembolism and Chronic Pain After Major Limb Trauma

Study acronym: THROMBO-PAIN
Not Yet Recruiting
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Summary
Major limb trauma is associated with a high risk of venous thromboembolism (VTE) due to systemic inflammation, endothelial injury, immobilization, and hypercoagulability. While VTE is commonly studied as a short-term complication affecting morbidity and mortality, its potential relationship with long-term pain outcomes after trauma has not been well investigated. This prospective observational cohort study aims to evaluate whether objectively confirmed VTE is associated with an increased risk of persistent clinically significant pain after major limb trauma. Adult patients with severe upper or lower limb injuries requiring surgical treatment or prolonged immobilization will be enrolled within 72 hours of hospital admission and followed for six months. The study will assess whether patients who develop VTE have a higher likelihood of persistent pain compared with those without VTE. In addition, the study will explore the association between baseline VTE risk (using the Trauma Embolic Scoring System, TESS), thromboprophylaxis timing, and long-term pain outcomes. Secondary analyses will evaluate neuropathic pain symptoms, pain interference with daily activities, quality of life, opioid consumption, and functional recovery. Understanding the relationship between thromboembolic complications and persistent pain may help improve risk stratification, optimize thromboprophylaxis strategies, and support early rehabilitation planning in patients with major limb trauma.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-13.
Trial Details
NCT Number NCT07475910
Lead Sponsor Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Conditions VTE (Venous Thromboembolism), Phantom Limb Pain After Amputation, Chronic Pain, Chronic Pain Due to Injury
Enrollment 150 participants
Start Date 2026-03-15
Primary Completion 2026-03-15 (estimated)
Study Completion 2026-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-18