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El ensayo clínico NCT07502313 (EVAC-PTSD Stud) para Amputación, TEPT, Combat Posttraumatic Stess Disorder, Combat Trauma está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation: A Prospective Cohort Study (EVAC-PTSD Stud) 300

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El ensayo clínico NCT07502313 (EVAC-PTSD Stud) es un estudio observacional para Amputación, TEPT, Combat Posttraumatic Stess Disorder, Combat Trauma. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 15 de marzo de 2026 hasta completar 300 participantes. Dirigido por Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans), se espera que finalice el 15 de noviembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 30 de marzo de 2026.
Resumen
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 m...Mostrar más
Descripción detallada
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 Ukrain...

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Título oficial

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

Condiciones médicas
AmputaciónTEPTCombat Posttraumatic Stess DisorderCombat Trauma
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • EVAC-PTSD Stud
  • 1303v04032026
  • Superhumans war trauma center (Otro identificador) (Superhumans war trauma center)
Número del NCT
NCT07502313
Inicio del estudio (real)
2026-03-15
Última actualización
2026-03-30
Fecha de finalización (estimada)
2026-11-15
Inscripción (prevista)
300
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
Post-Traumatic Stress Disorder
Combat Trauma
Amputation
Tourniquet Use
Evacuation Time
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
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...Mostrar más
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
PTSD severity measured by PCL-5 score
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.
18 months (baseline, 2, 6, 12, and 18 months follow-up)
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Change in PTSD Severity Over Time
Change in PTSD symptom severity measured as the difference in total PCL-5 score between baseline and follow-up assessments. This outcome will evaluate the trajectory of PTSD symptoms over time.
Baseline to 18 months
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Todos
  • 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

  • Prior PTSD diagnosis before current injury
  • Multiple amputations
  • Rehabilitation duration >3 months
  • Return to active military duty before follow-up completion
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) logoCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Parte responsable del estudio
Dmytro Dmytriiev, Investigador principal, Professor, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Contactos centrales del estudio
Contacto: Dmytro Dmytriiev, PhD.Professor, +380674309449, [email protected]
1 Centros del estudio en 1 países
Superhumans War Trauma Center, Lviv, Ukraine