Brain InjuriesNCT02510573
Low Serum Ficolin-3 Levels on Admission Are Associated With Poor Outcomes After Severe Traumatic Brain Injury
An observational study of Brain Injuries, run by Sanmen People's Hospital.
Trial summary
The current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Feb 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients with isolated head trauma and postresuscitation Glasgow Coma Scale score of 8 or less.
Who may be able to join
- Isolated head trauma
- Postresuscitation Glasgow Coma Scale score of 8 or less.
Who cannot join
- Less than 18 years of age
- Admission time > 6 hours
- Previous head trauma
- Neurological disease including ischemic or hemorrhagic stroke
- Use of antiplatelet or anticoagulant medication
- Diabetes mellitus
- Hypertension
- Presence of other prior systemic diseases including uremia, liver cirrhosis, malignancy, and chronic heart or lung disease
About this study
Official title: Prognostic Value of Serum Ficolin-3 Levels After Severe Traumatic Brain Injury：A Pilot Study
The current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury.
Read the detailed description
Complement activation is one of the pathological mechanisms that contribute to the secondary brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement activation contribute to the pathogenesis of ischemic stroke and may be additive to complement-independent inflammatory processes. Lower serum ficolin-3 levels have been demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This prospective observatory study was designed to investigate the relationship between serum ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls. Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and 6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels, correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential to be the useful, complementary tool to predict short- or long- term clinical outcome after severe traumatic brain injury.
- Conditions
- Brain Injuries
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sTBI group | The patients with isolated head trauma and postresuscitation GCS score of 8 or less. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality after severe traumatic brain injury
Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.
Measured: Follow-up of 6 months
Secondary outcomes (1)
Unfavorable outcome after severe traumatic brain injury
Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.
Measured: Follow-up of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startApr 2011
- Primary completionJul 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanmen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiongwei Gao, Sanmen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510573
- Sponsor's protocol ID
- SM2015119
- Status last verified
- Jul 2015
- First submitted
- 18 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serum Ficolin-3 Levels After Severe Traumatic Brain Injury：A Pilot Study
- ClinicalTrials.gov ID
- NCT02510573
- Acronym / sponsor ID
- SM2015119
- Conditions
- Brain Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sanmen People's HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Jul 2015 (estimated)
- 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 current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury.
Detailed description
Complement activation is one of the pathological mechanisms that contribute to the secondary brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement activation contribute to the pathogenesis of ischemic stroke and may be additive to complement-independent inflammatory processes. Lower serum ficolin-3 levels have been demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This prospective observatory study was designed to investigate the relationship between serum ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls. Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and 6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels, correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential to be the useful, complementary tool to predict short- or long- term clinical outcome after severe traumatic brain injury.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sTBI group | – | –The patients with isolated head trauma and postresuscitation GCS score of 8 or less. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with isolated head trauma and postresuscitation Glasgow Coma Scale score of 8 or less.
Key inclusion criteria (2 listed)
- Isolated head trauma
- Postresuscitation Glasgow Coma Scale score of 8 or less.
Key exclusion criteria (8 listed)
- Less than 18 years of age
- Admission time > 6 hours
- Previous head trauma
- Neurological disease including ischemic or hemorrhagic stroke
- Use of antiplatelet or anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality after severe traumatic brain injury
Time frame: Follow-up of 6 months
Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.
1 secondary outcome
Unfavorable outcome after severe traumatic brain injury
Time frame: Follow-up of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Sanmen People's Hospital.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality after severe traumatic brain injury (time frame: Follow-up of 6 months). 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 29 Jul 2015.