Venous Thromboembolism and Chronic Pain After Major Limb Trauma: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Persistent Clinically Significant Pain After Major Limb Trauma
研究概览
简要总结
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.
详细描述
Major limb trauma triggers a complex cascade of physiological responses, including systemic inflammation, endothelial injury, activation of coagulation pathways, and prolonged immobilization. These processes significantly increase the risk of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. VTE is a well-recognized complication following severe trauma and orthopedic injury and is typically studied in relation to acute morbidity and mortality.
However, the potential relationship between thromboembolic events and long-term pain outcomes has not been systematically investigated. Several biological mechanisms suggest a possible link between VTE and persistent post-traumatic pain. These mechanisms may include microvascular dysfunction and tissue hypoperfusion, persistent inflammatory activation, impaired rehabilitation due to thromboembolic complications, and amplification of peripheral and central sensitization pathways. These processes may contribute to prolonged nociceptive and neuropathic pain after trauma.
Patients with major limb trauma are also at risk for long-term functional impairment and chronic pain syndromes. Persistent post-traumatic pain may significantly affect rehabilitation, quality of life, and return to daily activities. Identifying early predictors of pain chronicity is therefore essential for improving long-term outcomes in trauma populations.
This prospective observational cohort study will investigate whether objectively confirmed VTE is independently associated with the development of persistent clinically significant pain following 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.
VTE will be defined as objectively confirmed deep vein thrombosis diagnosed by compression ultrasonography or pulmonary embolism confirmed by CT pulmonary angiography or ventilation-perfusion imaging. VTE events occurring during hospitalization or within 30 days after injury will be included in the exposure assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Major upper or lower limb trauma
- •Surgical treatment and/or immobilization ≥72 hours
- •Enrollment within 72 hours of admission
- •Informed consent
排除标准
- •Pre-existing chronic pain unrelated to trauma (investigator judgment)
- •Therapeutic anticoagulation prior to trauma
- •Cognitive inability to complete follow-up
- •Expected survival <48 hours
研究组 & 干预措施
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.
结局指标
主要结局
Persistent Clinically Significant Pain After Major Limb Trauma
时间窗: 3 months and 6 months after injury
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.
次要结局
- Opioid Consumption(Time Frame: up to 6 months after injury.)
- Neuropathic Pain(6 weeks, 3 months, and 6 months after injury.)
研究者
Dmytro Dmytriiev
Chief of science department, PhD, Professor
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)