A prospective, phase II, single centre, cross-sectional, randomised trial investigating Dehydroepiandrosterone and it's Pharmacokinetics in Trauma - A Dehydroepiandrosterone and Pharmacokinetics in Trauma study (ADaPT)

niversity Hospitals Birmingham0 个研究点目标入组 270 人开始时间: 2018年3月27日最近更新: 2019年6月30日

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•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.
•-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

•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

发起方

niversity Hospitals Birmingham