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Trial registered on ANZCTR


Registration number
ACTRN12623001129673
Ethics application status
Approved
Date submitted
6/10/2023
Date registered
2/11/2023
Date last updated
2/11/2023
Date data sharing statement initially provided
2/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Female RNA Concussion (FeRNAC) study protocol: Assessing Hormone Profiles and Salivary RNA in Females with Concussion by Emergency Departments in New Zealand; a prospective cohort study.
Scientific title
Female RNA Concussion (FeRNAC) study protocol: Assessing Hormone Profiles and Salivary RNA in Females with Concussion by Emergency Departments in New Zealand; a prospective cohort study.
Secondary ID [1] 310732 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FeRNAC study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 331673 0
Condition category
Condition code
Injuries and Accidents 328403 328403 0 0
Other injuries and accidents
Emergency medicine 328574 328574 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Females presenting to ED with a concussion. These patients will provide a saliva sample upon admission to ED when the concussion diagnosis is confirmed to investigate the presence of specific biomarkers and will exit the study when they are asymptomatic and have recovered from the concussion. The number of days it takes to recover will be recorded for a maximum of 3 months.
Intervention code [1] 327139 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336244 0
Presence of salivary biomarkers. The biomarkers investigated will be short non-coding Ribonucleic acids (sncRNA's).
Timepoint [1] 336244 0
At presentation to ED
Secondary outcome [1] 427519 0
Hormone profile
Timepoint [1] 427519 0
On entry into the study and then at 7 day time points until recovery
Secondary outcome [2] 427520 0
Risk for Low Energy Availability
Timepoint [2] 427520 0
On entry into the study and at 7 day time points until recovery
Secondary outcome [3] 427521 0
Symptom score
Timepoint [3] 427521 0
On presentation to ED with injury and at 7 day time points until recovery

Eligibility
Key inclusion criteria
Females of reproductive age – 16-50 years (with a menstrual cycle for a minimum of 2 years).

Natural regular menstrual cycle ~28-35 days long, or
Currently taking Oral Contraceptive Pill (OCP), or
Currently have Intra Uterine Device (IUD), or
Polycystic Ovarian Syndrome (PCOS), or
Oligomenorrheic (irregular periods), or
Amenorrheic (loss of periods for 3 months or longer)

Confirmed diagnosis of concussion by a medical doctor (within last 10 days)
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Had more than three or more previously diagnosed concussions.
Current concussion was more than 10 days ago.
Post-menopause.
Started taking medication that would alter reproductive hormone concentrations (Corticosteroids, e.g., Prednisone. Antidepressant or Antipsychotic medication) within the last 3 months.
Current clinical diagnosis of an eating disorder.
Pre-diagnosed psychiatric disorder.
Pre-diagnosed neurological condition.
GCS score less than 15 at 4 hours after initial assessment. These patients may be referred for a CT scan and will not be eligible for the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Using PASS15 software, and a Cox Proportional-Hazards regression model it was estimated that the number of partici-pants needed for the primary outcome (recovery time in days) to be statistically and clinically significant is 30. This will detect a hazard ratio of 1.5 (log hazard ratio coefficient = 0.4055), with 80% power, and a type I error rate of 0.05. This was calculated assuming a covariate SD of 1.5, a multiple regression R2 (variable of interest regressed on covariates) of 0.2, and an expected event (clinical recovery) rate of 0.9 within the follow-up period. Based on the power calculation using a 0.2 effect size with 80% power for the range of variables (based on means and SD reported in previous studies within the literature) and allowing for 20% drop out during follow-up, 38 participants will be recruited.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/01/2023
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
22/03/2024
Actual
Sample size
Target
38
Accrual to date
14
Final
Recruitment outside Australia
Country [1] 25853 0
New Zealand
State/province [1] 25853 0
Wellington

Funding & Sponsors
Funding source category [1] 314957 0
Government body
Name [1] 314957 0
The Accident Compensation Corporation
Country [1] 314957 0
New Zealand
Primary sponsor type
Individual
Name
Natalie Hardaker
Address
Sports Performance Research Institute NZ, Auckland University of Technology, 17 Antares Place, Rosedale, Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 316976 0
None
Name [1] 316976 0
Address [1] 316976 0
Country [1] 316976 0
Other collaborator category [1] 282835 0
Individual
Name [1] 282835 0
Professor Patria Hume
Address [1] 282835 0
Sports Performance Research Institute NZ, Auckland University of Technology, 17 Antares Place, Rosedale, Auckland, 0632
Country [1] 282835 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313936 0
Northern B, Health and Disability Ethics Committee
Ethics committee address [1] 313936 0
133 Molesworth Street, PO Box 5013
Ethics committee country [1] 313936 0
New Zealand
Date submitted for ethics approval [1] 313936 0
06/04/2022
Approval date [1] 313936 0
03/05/2022
Ethics approval number [1] 313936 0

Summary
Brief summary
This study aims to better understand how sex hormones impact on symptom severity and duration and salivary biomarker release in females following concussion and whether levels of hormones are related to symptoms after the injury.

Female sex hormones are linked to brain health and function; more female specific research is needed to understand how sex hormones influence brain injury.

There are differences in the way that males and females experience concussion. Diagnosis and management of concussion is symptom based. Even for highly trained doctors, it can sometimes be difficult to diagnose a concussion, and to understand why someone is having symptoms after injury. It can also be hard to track improvements and changes in symptoms during recovery from concussion to decide if someone is ready to return to school/work or sport. Going back to school/work or sport before you are fully recovered may make symptoms worse and last longer and may also increase the risk of sustaining a second injury.

Following concussion biomarkers are released into saliva. These molecules, small segments of cell Ribonucleic Acid (sncRNAs), offer a potential objective way to confirm diagnosis of concussion. These biomarkers have only been studied in males, it is not yet understood if the expression of sncRNA’s is influenced by the female sex hormones.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129846 0
Miss Natalie Hardaker
Address 129846 0
Sports Performance Research Institute NZ, Auckland University of Technology, 17 Antares Place, Rosedale, Auckland 0632
Country 129846 0
New Zealand
Phone 129846 0
+64 278989023
Fax 129846 0
Email 129846 0
natalie.hardaker@aut.ac.nz
Contact person for public queries
Name 129847 0
Miss Natalie Hardaker
Address 129847 0
Sports Performance Research Institute NZ, Auckland University of Technology, 17 Antares PLace, Rosedale, Auckland 0632
Country 129847 0
New Zealand
Phone 129847 0
+64 278989023
Fax 129847 0
Email 129847 0
natalie.hardaker@aut.ac.nz
Contact person for scientific queries
Name 129848 0
Miss Natalie Hardaker
Address 129848 0
Sports Performance Research Institute NZ, Auckland University of Technology, 17 Antares Place, Rosedale, Auckland 0632
Country 129848 0
New Zealand
Phone 129848 0
+64 278989023
Fax 129848 0
Email 129848 0
natalie.hardaker@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethical approval to share data. Unlikely to be any purpose to share IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20614Study protocol  natalie.hardaker@aut.co.nz
20615Statistical analysis plan  natalie.hardaker@aut.ac.nz
20616Informed consent form  natalie.hardaker@aut.ac.nz
20617Ethical approval  natalie.hardaker@aut.ac.nz
20618Other    Recruitment poster 386697-(Uploaded-06-10-2023-12-54-05)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.