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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ukrainian veterans with combat-related injury (post-February 2022)

Single limb amputation

Admission to rehabilitation within 2-4 months post-injury

Age ≥18 years

Disqualifiers

Prior PTSD diagnosis before current injury

Multiple amputations

Rehabilitation duration >3 months

Return to active military duty before follow-up completion

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Combat-Related Amputation Cohort

Trial outcomes

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.

Time frame
18 months (baseline, 2, 6, 12, and 18 months follow-up)

Secondary outcomes

1

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.

Time frame
Baseline to 18 months

Other outcomes

Sponsors and contacts

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