ISRCTN12961998
Completed
Phase 2
A prospective, phase II, single centre, cross-sectional, randomised trial investigating dehydroepiandrosterone and its pharmacokinetics in trauma
niversity Hospitals Birmingham NHS Foundation Trust0 sites68 target enrollmentJune 4, 2018
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Severe trauma injury
- Sponsor
- niversity Hospitals Birmingham NHS Foundation Trust
- Enrollment
- 68
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34312190/ (added 28/07/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 12/01/2021:
- •Trauma patients:
- •1\. 16 \- 50 years of age
- •2\. Severe trauma injury (Injury severity score (ISS) \=16 and \=50\)
- •3\. Admitted to University Hospital Birmingham within 6 days of trauma
- •4\. Anticipated to be an inpatient for the 12 day trial period
- •Hip fracture patients:
- •1\. 50 years or age and older
- •3\. Neck of Femur fracture
- •4\. Admitted to University Hospital Birmingham within 6 days of fracture
Exclusion Criteria
- •Current exclusion criteria as of 12/10/2021:
- •Trauma patients:
- •1\. Ages 51 years of age
- •3\. Isolated brain injury
- •4\. Unlikely to survive the trial period
- •5\. Previous or known hormone\-sensitive malignancy
- •6\. Known Prostatic hypertrophy (M)
- •7\. Female patients taking Hormonal Replacement Therapy medication or Oral Contraceptives
- •8\. Intake of any drug that has a major or moderate effect on the steroid synthesis or metabolism (see list in appendix 1\) in the last 3 months
- •9\. Pre\-existing liver impairment or chronic liver failure
Outcomes
Primary Outcomes
Not specified
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