Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation

NCT07502313 — Not yet recruiting, 300 participants, Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

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

Registry	NCT07502313, acronym EVAC-PTSD Stud
Status	Not yet recruiting
Study type	Observational
Enrollment	300 (Estimated)
Sponsor	Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) (Other)
Conditions	Amputation, PTSD, Combat Posttraumatic Stess Disorder, Combat Trauma
Dates	start 2026-03-15 (estimated), primary completion 2026-11-15 (estimated), completion 2026-11-15 (estimated), first posted 2026-03-30, last updated 2026-04-03
Locations	1 site in Ukraine

-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 months to identify key predictors of PTSD and to assess their interaction.

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+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 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.

+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

PTSD severity measured by PCL-5 score [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.

Secondary outcomes

Change in PTSD Severity Over Time [Baseline to 18 months]: 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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Superhumans War Trauma Center	Lviv	Ukraine

+Publications

Results publication: Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. PMID 26606250