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Clinical Trial NCT07502313 (EVAC-PTSD Stud) for Amputation, PTSD, Combat Posttraumatic Stess Disorder, Combat Trauma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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

Not yet recruiting
Clinical Trial NCT07502313 (EVAC-PTSD Stud) is an observational study for Amputation, PTSD, Combat Posttraumatic Stess Disorder, Combat Trauma and is currently not yet recruiting. Enrollment is planned to begin on March 15, 2026 and continue until the study accrues 300 participants. Led by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans), this study is expected to complete by November 15, 2026. The latest data from ClinicalTrials.gov was last updated on March 30, 2026.
Brief Summary
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...Show More
Detailed Description
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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Official Title

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

Conditions
AmputationPTSDCombat Posttraumatic Stess DisorderCombat Trauma
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • EVAC-PTSD Stud
  • 1303v04032026
  • Superhumans war trauma center (Other Identifier) (Superhumans war trauma center)
NCT ID Number
NCT07502313
Start Date (Actual)
2026-03-15
Last Update Posted
2026-03-30
Completion Date (Estimated)
2026-11-15
Enrollment (Estimated)
300
Study Type
Observational
Status
Not yet recruiting
Keywords
Post-Traumatic Stress Disorder
Combat Trauma
Amputation
Tourniquet Use
Evacuation Time
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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...Show More
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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)
Study Responsible Party
Dmytro Dmytriiev, Principal Investigator, Professor, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Study Central Contact
Contact: Dmytro Dmytriiev, PhD.Professor, +380674309449, [email protected]
1 Study Locations in 1 Countries
Superhumans War Trauma Center, Lviv, Ukraine