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

NCT07502313 | Not Yet Recruiting

• 2 other identifiers: 1303v04032026Superhumans war trauma center
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Amputation; PTSD; Combat Posttraumatic Stess Disorder; Combat Trauma

Keywords

Post-Traumatic Stress Disorder; Combat Trauma; Amputation; Tourniquet Use; Evacuation Time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in PTSD Severity Over Time

  Baseline to 18 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; d.dmytriiev@superhumans.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 30, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

UA (1)