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临床试验/NCT07502313
NCT07502313尚未招募不适用

Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation: A Prospective Cohort Study

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
PTSD severity measured by PCL-5 score

研究概览

简要总结

This study aims to evaluate the relationship between evacuation time, tourniquet use, and the development of post-traumatic stress disorder (PTSD) in patients with combat-related amputations. In the context of modern warfare, prolonged evacuation times and extended tourniquet application may contribute not only to physical injury but also to psychological trauma. The study will prospectively follow patients over 18 months to identify key predictors of PTSD and to assess their interaction.

详细描述

Combat-related amputations are frequently associated with prolonged evacuation times and the use of hemostatic tourniquets. While these factors are critical for survival, their potential contribution to long-term psychological outcomes remains insufficiently studied.

This prospective longitudinal study will investigate how evacuation delays and tourniquet duration influence the development of PTSD symptoms in Ukrainian veterans with limb amputations. The study will also evaluate the interaction between these factors and their cumulative psychological impact.

Participants will be followed for 18 months using validated PTSD screening tools, including the PCL-5 questionnaire, combined with retrospective analysis of medical records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ukrainian veterans with combat-related injury (post-February 2022)
  • Single limb amputation
  • Admission to rehabilitation within 2-4 months post-injury
  • Age ≥18 years
  • Ability to provide informed consent

排除标准

  • Prior PTSD diagnosis before current injury
  • Multiple amputations
  • Rehabilitation duration >3 months
  • Return to active military duty before follow-up completion

研究组 & 干预措施

Combat-Related Amputation Cohort

Participants in this cohort are Ukrainian veterans with combat-related single-limb amputations who are undergoing rehabilitation within the Superhumans Center network. All participants are enrolled within 2-4 months following injury and are followed prospectively for 18 months.

This is an observational study with no interventional treatment assigned. The primary exposures of interest are evacuation time and duration of tourniquet use, obtained from medical records. Participants undergo structured psychological assessment using validated instruments, including the PTSD Checklist for DSM-5 (PCL-5), at predefined time points during rehabilitation and follow-up.

The study aims to evaluate the association between these exposure variables and the development and progression of post-traumatic stress disorder (PTSD), as well as to assess their combined and interaction effects on psychological outcomes.

结局指标

主要结局

PTSD severity measured by PCL-5 score

时间窗: 18 months (baseline, 2, 6, 12, and 18 months follow-up)

Severity of post-traumatic stress disorder (PTSD) symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a validated 20-item self-report questionnaire. Each item is scored on a scale from 0 (not at all) to 4 (extremely), with a total score range of 0 to 80, where higher scores indicate greater symptom severity. The primary outcome will be the total PCL-5 score measured longitudinally to evaluate changes in PTSD symptom severity over time and its association with evacuation time and duration of tourniquet use.

次要结局

  • Change in PTSD Severity Over Time(Baseline to 18 months)

研究者

发起方
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmytro Dmytriiev

Professor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

研究点 (1)

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