Status:

COMPLETED

PRIME: Cognitive Outcome Following Major Burns

Lead Sponsor:

Chelsea and Westminster NHS Foundation Trust

Collaborating Sponsors:

University of Westminster

Imperial College Healthcare NHS Trust

Conditions:

Cognitive Dysfunction

Burns

Eligibility:

All Genders

18+ years

Brief Summary

PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a degree of neurocognitive dysfunction following a major burn, that this neurocognitive dysfunction is due to a...

Detailed Description

Patients were matched with for age, sex and IQ (as determined by National Adult Reading Test scores) controlled volunteers. Participants were assessed for the following domains: verbal ability, verba...

Eligibility Criteria

Inclusion

  • Invasive ventilation on a Burns Intensive Care Unit (BICU) within the previous ten years
  • Burn injuries greater than 15% total body surface area (TBSA)
  • Adult

Exclusion

  • Admission to BICU for other illnesses that were not burn related (such as Toxic Epidermal Necrolysis Syndrome)
  • Evidence of head trauma
  • Known substance misuse or alcohol excess
  • Inability to understand plain verbal or written English
  • Severe mental health issues
  • Receiving formal psychiatric treatment
  • Currently held under the Mental Health Act
  • If the subject's psychological health was deemed to be at risk from inclusion
  • Imprisoned
  • Contraindications to MRI
  • non-compatible pacemakers
  • surgical metalwork or foreign bodies
  • severe claustrophobia

Key Trial Info

Start Date :

October 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2017

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03242395

Start Date

October 1 2014

End Date

April 1 2017

Last Update

August 8 2017

Active Locations (1)

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Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom, SW10 9NH