Venous Thromboembolism and Chronic Pain After Major Limb Trauma
Not yet recruitingNCT07475910
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Venous Thromboembolism and Chronic Pain After Major Limb Trauma: A Prospective Cohort Study
- Conditions
- VTE (Venous Thromboembolism)
- Phantom Limb Pain After Amputation
- Chronic Pain
- Chronic Pain Due to Injury
- Sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Start date
- 2026-03-15
- Primary completion
- 2026-03-15
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Ukraine
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥18 years * Major upper or lower limb trauma * Surgical treatment and/or immobilization ≥72 hours * Enrollment within 72 hours of admission * Informed consent Exclusion Criteria: * Pre-existing chronic pain unrelated to trauma (investigator judgment) * Therapeutic anticoagulation prior to trauma * Cognitive inability to complete follow-up * Expected survival \<48 hours
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07475910