Traumatic Brain InjuryFIRST DOWNNCT03060109
Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System
An observational study of Traumatic Brain Injury, run by Banyan Biomarkers, Inc at 4 sites in Netherlands.
Trial summary
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Blood draw within 12 hours of injury
- How many people
- 317 participants
- Where
- 4 sitesNetherlands
- Study dates
- 21 Jun 2016to 10 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected head injury subjects over the age of 18 who present to the HCF or ED within 12 hours from the time of head injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.
Who may be able to join
- The Subject is at least 18 years of age at screening.
- The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
- The venous blood sample is collected no later than 12 hours from the time of head injury.
- The Subject is competent and willing to undergo the Informed Consent process
Who cannot join
- Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
- Time of suspected head injury cannot be determined.
- Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
- Blood transfusion after head injury, and prior to study blood draw
- Blood donation within 1 week of study enrollment.
- The subject is a female who is pregnant or lactating.
- The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Maastricht University Medical Center
Maastricht, 6202 AZ
Radboud University Medical Center
Nijmegen, 6525 GA
Erasmus Medical Center
Rotterdam, 3000 CA
Haaglanden MC Westeinde
The Hague, 2512 VA
About this study
Official title: Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.
- Conditions
- Traumatic Brain Injury
- Being tested
- Blood draw within 12 hours of injury
- Keywords
- Traumatic brain injury, Head injury
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw within 12 hours of injuryOther
| Study group | Role | What they receive |
|---|---|---|
| Suspected traumatic brain injury | Not described Receives: Other: Blood draw within 12 hours of injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of biomarkers
Measurement of UCH-L1 and GFAP using Philips Minicare
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start21 Jun 2016
- Primary completion10 Sep 2017
- Study completion10 Sep 2017
Why it stopped: Diagnostic platform no longer under development; study termination not related to any safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banyan Biomarkers, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060109
- Sponsor's protocol ID
- ATO-13
- Acronym
- FIRST DOWN
- Status last verified
- Sep 2017
- First submitted
- 17 Feb 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh Intravenous Blood Samples for TBI Diagnostic Assay Development With Philips Point of Care System (FIRST DOWN)
- ClinicalTrials.gov ID
- NCT03060109
- Acronym / sponsor ID
- FIRST DOWN / ATO-13
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Head injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Diagnostic platform no longer under development; study termination not related to any safety issues
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Banyan Biomarkers, IncIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 10 Sep 2017 (actual)
- Study completion
- 10 Sep 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect fresh whole blood within 12 hours from suspected mild head injury (Glasgow Coma Scale score 13-15) from subjects over the age of 18, to help verify that both UCH-L1 and GFAP can be detected with the Philips Minicare POC diagnostic test platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected traumatic brain injury | – | Other: Blood draw within 12 hours of injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected head injury subjects over the age of 18 who present to the HCF or ED within 12 hours from the time of head injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.
Key inclusion criteria (5 listed)
- The Subject is at least 18 years of age at screening.
- The Subject has presented to a Health Care Facility or Emergency Department with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
- The Subject has a Glasgow Coma Scale score of 13-15 at the time of Informed Consent.
- The venous blood sample is collected no later than 12 hours from the time of head injury.
- The Subject is competent and willing to undergo the Informed Consent process
Key exclusion criteria (7 listed)
- Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
- Time of suspected head injury cannot be determined.
- Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
- Blood transfusion after head injury, and prior to study blood draw
- Blood donation within 1 week of study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw within 12 hours of injury | Other | Suspected traumatic brain injury |
Primary outcome
Measurement of biomarkers
Time frame: 12 hours
Measurement of UCH-L1 and GFAP using Philips Minicare
Results and safety
The study was stopped early (reason given: Diagnostic platform no longer under development; study termination not related to any safety issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Banyan Biomarkers, Inc at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Diagnostic platform no longer under development; study termination not related to any safety issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of biomarkers (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.