Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000545460
Ethics application status
Approved
Date submitted
18/10/2007
Date registered
23/10/2007
Date last updated
23/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effects of progesterone on neurologic outcome of the patients with severe traumatic brain injury
Scientific title
Evaluating the effects of progesterone on neurologic outcome of the patients with severe traumatic brain injury
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
to evaluating the effects of progesterone on neurologic outcome of the patients with severe traumatic brain injury 2489 0
Condition category
Condition code
Surgery 2574 2574 0 0
Other surgery
Injuries and Accidents 2587 2587 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progesterone were administered at 1.0mg/kg via intramuscular injection at admission immediately and then once per 12h for 5 consecutive days respectively.
Intervention code [1] 2203 0
Treatment: Drugs
Comparator / control treatment
sterile normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 3480 0
Glasgow Coma Score (GCS)
Timepoint [1] 3480 0
3 and 6 months follow-up
Primary outcome [2] 3497 0
Glasgow Outcome Scale (GOS); The modified Functional Independence Measure (FIM) score
Timepoint [2] 3497 0
3- and 6-months follow-up
Secondary outcome [1] 5810 0
The modified Functional Independence Measure (FIM) score
Timepoint [1] 5810 0
3 and 6 months follow-up
Secondary outcome [2] 5835 0
Glasgow Outcome Scale (GOS); The modified Functional Independence Measure (FIM) score
Timepoint [2] 5835 0
3 and 6 months follow-up

Eligibility
Key inclusion criteria
severe traumatic brain injury , Glasgow Coma Scale (GCS) score of 8 or less after resuscitation and stabilization and between the ages of 15 and 65 years were entered into the study.
Minimum age
15 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
received any investigational drug; severe anoxic intracerebral damage or brain death; clinical condition was unstable; with pregnancy and female patients during lactation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment method was used central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment outside Australia
Country [1] 626 0
China
State/province [1] 626 0

Funding & Sponsors
Funding source category [1] 2728 0
Government body
Name [1] 2728 0
the Scientific Research Fund of Zhejiang Provincial Education Department
Country [1] 2728 0
China
Primary sponsor type
Hospital
Name
the Affiliated Hospital, School of Medicine, Hangzhou Normal University
Address
the Affiliated Hospital, School of Medicine, Hangzhou Normal University, Hangzhou, China.
Country
China
Secondary sponsor category [1] 2464 0
Hospital
Name [1] 2464 0
the Second Affiliated Hospital, School of Medicine, Zhejiang University
Address [1] 2464 0
the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Country [1] 2464 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose in this clinical study was to evaluate the effects of progesterone on functional outcome of the patients with severe head injury.
Progesterone, a hormone, has steroidal, neuroactive and neurosteroidal action in the center neuronal system. Recently, neuroprotective effects of progesterone have been shown in a variety of animal models including ischemic and traumatic brain insults models. Post-injury administration of progesterone in head injury subjects confers significant protection against injury-induced cerebral edema and secondary neuronal death, promoting behavioral recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28125 0
Address 28125 0
Country 28125 0
Phone 28125 0
Fax 28125 0
Email 28125 0
Contact person for public queries
Name 11282 0
Guo-min Xiao
Address 11282 0
Department of Neurosurgery and Neurotrauma Center, the Affiliated Hospital, School of Medicine, Hangzhou Normal University, Hangzhou, China.
Country 11282 0
China
Phone 11282 0
86-571-88303638
Fax 11282 0
Email 11282 0
[email protected]
Contact person for scientific queries
Name 2210 0
Department of Neurosurgery and Neurotrauma Center, the Affiliated Hospital, School of Medicine, Hangzhou Normal University
Address 2210 0
Department of Neurosurgery and Neurotrauma Center, the Affiliated Hospital, School of Medicine, Hangzhou Normal University, Hangzhou, China.
Country 2210 0
China
Phone 2210 0
86-571-88303638
Fax 2210 0
Email 2210 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePharmacological components with neuroprotective effects in the management of traumatic brain injury: evidence from network meta-analysis.2023https://dx.doi.org/10.1007/s10072-023-06600-7
N.B. These documents automatically identified may not have been verified by the study sponsor.