Evacuation Time and Tourniquet Use as Risk Factors for PTSD in Combat-Related Amputation (EVAC-PTSD Stud)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PTSD; Amputation; Combat Posttraumatic Stess Disorder; Combat Trauma

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dmytro Dmytriiev, PhD.Professor; Phone Number: +380674309449; Email: d.dmytriiev@superhumans.com

Study Locations

• Ukraine
  • Lviv, Ukraine
    • Superhumans War Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of Ukrainian military veterans who sustained combat-related traumatic injuries resulting in a single-limb amputation. Participants are recruited from rehabilitation centres within the Superhumans Center network (Lviv, Dnipro, and Odesa, Ukraine).

Eligible participants are adults (≥18 years) who were injured after February 2022 and are admitted to rehabilitation within 2-4 months following injury. The study focuses on individuals with no prior history of post-traumatic stress disorder (PTSD) to allow assessment of incident PTSD related to the current trauma.

This population represents patients exposed to high-energy combat injuries, often associated with prolonged evacuation times and the use of hemostatic tourniquets. The cohort is therefore particularly relevant for investigating the relationship between prehospital factors and long-term psychological outcomes.

Participants are followed prospectively for 18 months with repeated psychological assessment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Post-Traumatic Stress Disorder; Amputation; Combat Trauma; Tourniquet Use; Evacuation Time
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1303v04032026; Superhumans war trauma center (Other Identifier: Superhumans war trauma center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Individual participant data (IPD) will not be publicly shared due to the sensitive nature of the study population, which includes military veterans with combat-related injuries and psychological outcomes. Although all data will be de-identified prior to analysis, there remains a potential risk of re-identification.

Data may be made available upon reasonable request to the principal investigator for scientifically valid research purposes, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No