A Dehydroepiandrosterone and Pharmacokinetics in Trauma study (ADaPT)

Phase 2

Completed

• Conditions: Severe trauma injury; Injury, Occupational Diseases, Poisoning; Injuries to unspecified part of trunk, limb or body region

• Registration Number: ISRCTN12961998
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34312190/ (added 28/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-04
• Study Completion: 2022-04-30
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

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
2. Female
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
2. Female
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

Exclusion Criteria

Current exclusion criteria as of 12/10/2021:

Trauma patients:
1. Ages 51 years of age
2. ISS 50
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:
1.
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
2. ISS 50
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified