Establishing a dose of hormone supplementation in trauma patients that will increase hormone levels in the body

Phase 1

• Conditions: DHEA depletion in trauma and hip fracture patients.; MedDRA version: 20.0 Level: PT Classification code 10056629 Term: Dehydroepiandrosterone decreased System Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2016-004250-15-GB
• Lead Sponsor: niversity Hospitals Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

The inclusion criteria is split into trauma patients and hip fracture patient cohorts.

TRAUMA PATIENTS INCLUSION CRITERIA (males and females)
-16 - 50 years of age
-Severely injured trauma patient (Injury severity score (ISS) =16 and =50)
-Admitted to University Hospital Birmingham within 6 days of trauma
-Anticipated to be an inpatient for the 11 day trial period

HIP FRACTURE PATIENTS INCLUSION CRITERIA (females only)
-50 years of age and older.
-Female.
-Neck of Femur fracture.
-Admitted to University Hospital Birmingham within 6 days of fracture.
-Anticipated to be an inpatient for the 11 day trial period.

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

The exclusion criteria is split into trauma patients and hip fracture patient cohorts.

TRAUMA PATIENTS EXCLUSION CRITERIA
1.Ages <16 or >51 years of age.
2.ISS <16 or >50
3.Isolated brain injury.
4.Unlikely to survive the study period (11 days).
5.Previous or known hormone sensitive malignancy.
6.Known Prostatic hypertrophy (M)
7.Intake of adrenal medication prior to admission to hospital.
8.Female patients taking Hormone Replacement Therapy medication.
9.Intake of any drugs that is likely to influence the metabolism of steroids, in particular inducers and
inhibitors of the drug-metabolising enzyme CYP3A4 in the last 3 months.
10.Previous documented liver failure.
11.Current malignancy with ongoing active treatment.
12.Prescribed antipsychotic medication.
13. Pregnant and/or breast-feeding females

HIP FRACTURE PATIENTS EXCLUSION CRITERIA
1.<50 years of age.
2.Unlikely to survive the study period (11 days).
3.Previous or known hormone sensitive malignancy.
4.Intake of any drugs that is likely to influence the metabolism of steroids, in particular inducers and
inhibitors of the drug-metabolising enzyme CYP3A4 in the last 3 months.
5.Previous documented liver failure.
6.Current malignancy with ongoing active treatment.
7.Prescribed antipsychotic medication.
8. Pregnant and/or breast-feeding females

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified