The purpose of this study is to collect fresh whole blood from subjects who have had a suspected head injury (Glasgow Coma Scale score 9-15), for use during the early phase of development of an investigational diagnostic assay platform (Philips…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
traumatisch hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The purpose of this study is to collect fresh whole blood from subjects who
have had a suspected mild to moderate head injury (Glasgow Coma Scale score
9-15), for testing and evaluation of an investigational diagnostic assay
platform (Philips Minicare POC). The fresh whole blood samples collected in
this study will be used to help verify that both UCH-L1 and GFAP can be
detected with the Philips Minicare POC diagnostic test platform. The
procedures for testing specimens on the Philips Minicare POC, including the
criteria for demonstrating proficiency of assay performance, will be described
in a separate protocol maintained by the Sponsor. If successful, a clinical
study will be designed and conducted to validate that the Philips Minicare POC
diagnostic test meets the proposed Intended Use.
Secondary outcome
NA
Background summary
Traumatic brain injury (TBI) is a significant public health problem
representing a potentially catastrophic and debilitating medical emergency. The
current standard of care has significant limitations, and many patients who
suffer TBI do not receive medical care because the effects of TBI are often not
immediately or outwardly visible. There exists an unmet medical need to
improve the diagnosis and management of TBI. A biomarker test for TBI has the
potential to greatly improve the triage and management of head injured
patients, and at the same time, prevent the unnecessary use of neuroimaging and
radiation exposure to patients.
Study objective
The purpose of this study is to collect fresh whole blood from subjects who
have had a suspected head injury (Glasgow Coma Scale score 9-15), for use
during the early phase of development of an investigational diagnostic assay
platform (Philips Minicare POC).
Study design
This is a prospective study that will enroll up to 500 subjects over a period
of 2 years at up to 5 centers who present to the health care facility (HCF) or
Emergency Department (ED) with suspected head injury and an initial GCS of 9-15
Study burden and risks
The study poses negligible risk to subjects. The collection of specimens is
minimally invasive, and largely consists of standard specimen collection
procedures used in the evaluation of TBI. These do not pose a health hazard to
the subject. The informed consent form will describe the potential risks to the
subjects.
West Bernardo Drive 16744
San Diego 92127
US
West Bernardo Drive 16744
San Diego 92127
US
Listed location countries
Age
Inclusion criteria
1. The Subject is at least 18 years of age at screening.
2. The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
3. The Subject has a Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
4. The venous blood sample is collected no later than 12 hours from the time of head injury.
5. The Subject or their Next of Kin is willing to undergo the Informed Consent process prior to enrollment into this study
Exclusion criteria
1. Participating in any other interventional, therapeutic clinical study (an observational study would be acceptable).
2. Time of suspected head injury cannot be determined.
3. 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)).
4. Blood transfusion after head injury, and prior to study blood draw
5. Blood donation within 1 week of study enrollment.
6. The subject is a female who is pregnant or lactating.
7. The Subject is otherwise determined by the Principal Investigator to be an unsuitable candidate for participation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02541123 |
| CCMO | NL56548.091.16 |