ISRCTN12961998已完成2 期
A prospective, phase II, single centre, cross-sectional, randomised trial investigating dehydroepiandrosterone and its pharmacokinetics in trauma
niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 68 人开始时间: 2018年6月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34312190/ (added 28/07/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •5. Anticipated to be an inpatient for the 12 day trial period
- •Previous inclusion criteria:
- •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 11 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
- •5. Anticipated to be an inpatient for the 11 day trial period
排除标准
- •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
- •10. Previous or current malignancy or invasive cancer diagnosed within the past 3 years except for adequately treated basal cell and squamous cell carcinoma of the skin and in situ carcinoma of the uterine cervix
- •11. Pregnant and/or breastfeeding females (Serum pregnancy tests to be carried out on women of childbearing potential)
- •12. Known hypersensitivity to the active substance or excipient
- •13. Known thromboembolic events in the last 12 months and any predisposition to thrombosis e.g. factor V Leiden
- •Hip fracture patients:
- •2. Unlikely to survive the study period
- •3. Previous or known hormone-sensitive malignancy
- •4. 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
- •5. Known pre-existing liver impairment or chronic liver failure
- •6. Previous or current malignancy or invasive cancer diagnosed within the past 3 years except for adequately treated basal cell and squamous cell carcinoma of the skin and in situ carcinoma of the uterine cervix
- •7. Pregnant and/or breastfeeding (Serum pregnancy tests to be carried out on women of childbearing potential)
- •8. Known hypersensitivity to the active substance or excipient
- •9. Patients on Hormonal Replacement Therapy medication or Oral Contraceptives
- •10. Known thromboembolic events in the last 12 months and any predisposition to thrombosis e.g. factor V Leiden
- •Previous exclusion criteria as of 12/01/2021:
- •Trauma patients:
- •1. Ages 51 years of age
- •3. Isolated brain injury
- •4. Unlikely to survive the study period
- •5. Previous or known hormone-sensitive malignancy
- •6. Known Prostatic hypertrophy (M)
- •7. Female patients taking Hormone Replacement Therapy medication
- •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
- •10. Previous or current malignancy or invasive cancer diagnosed within the past 3 years except for adequately treated basal cell and squamous cell carcinoma of the skin and in situ carcinoma of the uterine cervix
- •11. Pregnant and/or breastfeeding females (Serum pregnancy tests to be carried out on women of childbearing potential)
- •12. Known hypersensitivity to the active substance or excipient
- •13. Known thromboembolic events in the last 12 months and any predisposition to thrombosis e.g. factor V Leiden
- •Hip fracture patients:
- •1. <50 years of age
- •2. Unlikely to survive the study period
- •3. Previous or known hormone-sensitive malignancy
- •4. 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
- •5. Known pre-existing liver impairment or chronic liver failure
- •6. Previous or current malignancy or invasive cancer diagnosed within the past 3 years except for adequately treated basal cell and squamous cell carcinoma of the skin and
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