Traumatic Brain InjuryNCT04524637
The Utility of Thromboelastography in Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Coagulation Disorder, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury, Coagulation Disorder
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-80 years old) with isolated traumatic brain injury, who are admitted within 24 hours post-injury are included. To avoid interfering factors, patients with existing prior neurological disease or known coagulation disorders, patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma or receiving blood components prior to blood draw, patients who deteriorate and die before determining whether coagulation-related damage exists are excluded. Clinical data are documented, including age, gender, mechanisms of trauma, types of lesions as evidenced by imaging examination and laboratory examination, etc.
Who may be able to join
- Patients who are delivered to hospital within 24 hours after head trauma
- Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury
Who cannot join
- Patients with existing prior neurological disease
- Patients with known coagulation disorders
- Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma
- Patients receiving blood components prior to blood draw
- Patients who deteriorate and die before determining whether coagulation- related damage exists
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200233
Hao Chen, M.D., Ph.D.
About this study
Official title: The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury
Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.
- Conditions
- Traumatic Brain Injury, Coagulation Disorder
- Keywords
- Thrombelastography, Coagulation Disorder, Traumatic Brain Injury, Coagulation-related damages
- Medical subject headings
- Brain Injuries, Traumatic, Hemostatic Disorders
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 |
|---|---|---|
| Traumatic brain injury | Patients who are delivered within 24 hours after head trauma and sustain isolated traumatic brain injury are included in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale scores
Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome is defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome is defined as a Glasgow Outcome Scale score of > 3.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, MD, PhD, Shanghai 6th People's Hospital
- Investigators
- Hao Chen, M.D., Ph.D., Study director, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524637
- Sponsor's protocol ID
- 18PJD034
- Status last verified
- Mar 2025
- First submitted
- 20 Aug 2020
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Thromboelastography for Predicting the Risk of Coagulation-Related Damages Secondary to Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04524637
- Acronym / sponsor ID
- 18PJD034
- Conditions
- Traumatic Brain Injury, Coagulation Disorder
- Keywords
- Thrombelastography, Coagulation Disorder, Traumatic Brain Injury, Coagulation-related damages
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Aug 2020 (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.
Hemocoagulation disorder is recognized to have crucial effects on hemorrhagic or ischemic diseases. Coagulation-related damages secondary to traumatic brain injury are common and severe secondary insults of head trauma and often leads to a poor prognosis. In this study, we sought to assess if posttraumatic hemocoagulation disorders determined using thromboelastography are associated with coagulation-related damages secondary to traumatic brain injury, and evaluate their influence on outcome among patients with head trauma. Based on above results, prediction models or risk scoring systems will be further developed and validated to predict coagulation-related damages secondary to traumatic brain injury.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury | – | –Patients who are delivered within 24 hours after head trauma and sustain isolated traumatic brain injury are included in this study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-80 years old) with isolated traumatic brain injury, who are admitted within 24 hours post-injury are included. To avoid interfering factors, patients with existing prior neurological disease or known coagulation disorders, patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma or receiving blood components prior to blood draw, patients who deteriorate and die before determining whether coagulation-related damage exists are excluded. Clinical data are documented, including age, gender, mechanisms of trauma, types of lesions as evidenced by imaging examination and laboratory examination, etc.
Key inclusion criteria (2 listed)
- Patients who are delivered to hospital within 24 hours after head trauma
- Patients whose abbreviated injury score (AIS) for other body regions is 3 or less are considered to be isolated traumatic brain injury
Key exclusion criteria (5 listed)
- Patients with existing prior neurological disease
- Patients with known coagulation disorders
- Patients on anticoagulants and medications known to affect coagulation function within 30 days before trauma
- Patients receiving blood components prior to blood draw
- Patients who deteriorate and die before determining whether coagulation- related damage exists
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
Glasgow Outcome Scale scores
Time frame: Six months
Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery. Unfavorable outcome is defined as a Glasgow Outcome Scale score of ≤ 3, and favorable outcome is defined as a Glasgow Outcome Scale score of > 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Hao Chen, M.D., Ph.D. study director
Shanghai 6th People's Hospital
1 site 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 and Coagulation Disorder, run by Shanghai 6th People's Hospital at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Chen, M.D., Ph.D. (86-21-64369181 ext. 8405, chenhao_316@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale scores (time frame: Six 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 17 Mar 2025.