Venous Thromboembolism and Chronic Pain After Major Limb Trauma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years

Major upper or lower limb trauma

Surgical treatment and/or immobilization ≥72 hours

Enrollment within 72 hours of admission

Disqualifiers

Pre-existing chronic pain unrelated to trauma (investigator judgment)

Therapeutic anticoagulation prior to trauma

Cognitive inability to complete follow-up

Expected survival <48 hours

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

150 Participants
are grouped into 1 trial group