Venous Thromboembolism and Chronic Pain After Major Limb Trauma

NCT07475910 | Not Yet Recruiting

• 2 other identifiers: 1303v03032026Superhumans war trauma center
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

VTE (Venous Thromboembolism); Phantom Limb Pain After Amputation; Chronic Pain; Chronic Pain Due to Injury

Keywords

Venous thromboembolism; Post-traumatic chronic pain; Neuropathic pain; Major limb trauma; Trauma Embolic Scoring System (TESS)

Outcome Measures

Primary Outcomes (1)

• Persistent Clinically Significant Pain After Major Limb Trauma

  Persistent pain defined as Numeric Rating Scale (NRS) ≥4 during movement or functional activity at 3 or 6 months after injury. Pain intensity will be assessed using the standardized 0-10 Numeric Rating Scale during follow-up evaluations.

  3 months and 6 months after injury

Secondary Outcomes (2)

• Neuropathic Pain

  6 weeks, 3 months, and 6 months after injury.

• Opioid Consumption

  Time Frame: up to 6 months after injury.

Study Arms (1)

Major Limb Trauma Cohort

Adult patients with major upper or lower limb trauma requiring surgical treatment and/or prolonged immobilization (≥72 hours). Participants will be enrolled within 72 hours of admission and followed prospectively for 6 months to evaluate the association between venous thromboembolism (VTE) and persistent post-traumatic pain. VTE events will be identified during hospitalization or within 30 days after injury using standard diagnostic imaging.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients (≥18 years) with major upper or lower limb trauma requiring surgical treatment and/or prolonged immobilization (≥72 hours). Participants will be recruited from trauma centers managing severe civilian and combat-related injuries. Eligible patients will be enrolled within 72 hours of hospital admission. The cohort will include patients with various mechanisms of injury, including blast injuries, fragmentation injuries, gunshot wounds, and other high-energy trauma. Participants will be followed prospectively for up to 6 months to evaluate the association between venous thromboembolism (VTE) and the development of persistent post-traumatic pain.

You may qualify if:

• Age ≥18 years
• Major upper or lower limb trauma
• Surgical treatment and/or immobilization ≥72 hours
• Enrollment within 72 hours of admission
• Informed consent

You may not qualify if:

• Pre-existing chronic pain unrelated to trauma (investigator judgment)
• Therapeutic anticoagulation prior to trauma
• Cognitive inability to complete follow-up
• Expected survival \<48 hours

Sponsors & Collaborators

• Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans): lead

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

• Knudson MM, Ikossi DG, Khaw L, Morabito D, Speetzen LS. Thromboembolism after trauma: an analysis of 1602 episodes from the American College of Surgeons National Trauma Data Bank. Ann Surg. 2004 Sep;240(3):490-6; discussion 496-8. doi: 10.1097/01.sla.0000137138.40116.6c.

  PMID: 15319720 RESULT

MeSH Terms

Conditions

Venous Thromboembolism; Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Dmytro Dmitriy Dmytriiev, PhD.Professor

CONTACT

+380674309449; d.dmytriiev@superhumans.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of science department, PhD, Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)