Moderate Traumatic Brain InjuryIPMMTBINCT04900168
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
An observational study of Moderate Traumatic Brain Injury, run by Tang-Du Hospital at 1 site in China.
Trial summary
Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate Traumatic Brain Injury
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Jun 2027
- How long will I take part?
- 6 Months
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient with acute moderate traumatic brain injury
Who may be able to join
- History of head trauma
- 18 ≤ age ≤ 75 years
- Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
- Glasgow coma scale at admission: 9-13
- No pregnant
Who cannot join
- Refusing follow up visit
- Surgical treatment in other hospital before admission
- Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
- Estimated survival time less than 1 year
- Participating in other on-going clinical researches
- Other systemic diseases: uremia, liver cirrhosis, malignant tumor, mental illness, drug, or alcohol dependence, etc.
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
Tangdu Hospital
Xi'an, Shannxi Province
Zhihong Li, +86-13709183909, 409615390@qq.com
About this study
Official title: A Multi-center Observational Cohort Study of Management of Moderate Traumatic Brain Injury With or Without Intracranial Pressure Monitoring in Patients With Moderate Traumatic Brain Injury in China
Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China.
Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months.
Read more
Interventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension.
Sample Size and Population Sample size calculation: Not applicable. The sample size will be equal to the total number of moderate trumatic brain injury patients consecutively admitted to hospitals during the study period.
- Conditions
- Moderate Traumatic Brain Injury
- Keywords
- Intracranial Pressure
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 |
|---|---|---|
| all patients with moderate traumatic brain injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good neurologic outcome
The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury
Measured: Within 6 months after traumatic brain injury
Secondary outcomes (2)
6 months mortality
The mortality of patients in each group at 6 months after traumatic brain injury
Measured: Within 6 months after traumatic brain injury
In-hospital mortality
The mortality of patients in each group during hospitalization
Measured: Within 1 month after traumatic brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Moderate Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900168
- Sponsor's protocol ID
- 202102-18
- Acronym
- IPMMTBI
- Status last verified
- Nov 2026
- First submitted
- 7 Apr 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Godoy DA, Rubiano A, Rabinstein AA, Bullock R, Sahuquillo J. Moderate Traumatic Brain Injury: The Grey Zone of Neurotrauma. Neurocrit Care. 2016 Oct;25(2):306-19. doi: 10.1007/s12028-016-0253-y.
PubMed 26927279Hawryluk GW, Manley GT. Classification of traumatic brain injury: past, present, and future. Handb Clin Neurol. 2015;127:15-21. doi: 10.1016/B978-0-444-52892-6.00002-7.
PubMed 25702207Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
PubMed 28504109Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
PubMed 27654000Watanitanon A, Lyons VH, Lele AV, Krishnamoorthy V, Chaikittisilpa N, Chandee T, Vavilala MS. Clinical Epidemiology of Adults With Moderate Traumatic Brain Injury. Crit Care Med. 2018 May;46(5):781-787. doi: 10.1097/CCM.0000000000002991.
PubMed 29369057Lobato RD, Rivas JJ, Gomez PA, Castaneda M, Canizal JM, Sarabia R, Cabrera A, Munoz MJ. Head-injured patients who talk and deteriorate into coma. Analysis of 211 cases studied with computerized tomography. J Neurosurg. 1991 Aug;75(2):256-61. doi: 10.3171/jns.1991.75.2.0256.
PubMed 2072163Peterson EC, Chesnut RM. Talk and die revisited: bifrontal contusions and late deterioration. J Trauma. 2011 Dec;71(6):1588-92. doi: 10.1097/TA.0b013e31822b791d.
PubMed 22182868Compagnone C, d'Avella D, Servadei F, Angileri FF, Brambilla G, Conti C, Cristofori L, Delfini R, Denaro L, Ducati A, Gaini SM, Stefini R, Tomei G, Tagliaferri F, Trincia G, Tomasello F. Patients with moderate head injury: a prospective multicenter study of 315 patients. Neurosurgery. 2009 Apr;64(4):690-6; discussion 696-7. doi: 10.1227/01.NEU.0000340796.18738.F7.
PubMed 19197220Balestreri M, Czosnyka M, Hutchinson P, Steiner LA, Hiler M, Smielewski P, Pickard JD. Impact of intracranial pressure and cerebral perfusion pressure on severe disability and mortality after head injury. Neurocrit Care. 2006;4(1):8-13. doi: 10.1385/NCC:4:1:008.
PubMed 16498188Juul N, Morris GF, Marshall SB, Marshall LF. Intracranial hypertension and cerebral perfusion pressure: influence on neurological deterioration and outcome in severe head injury. The Executive Committee of the International Selfotel Trial. J Neurosurg. 2000 Jan;92(1):1-6. doi: 10.3171/jns.2000.92.1.0001.
PubMed 10616075Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.
PubMed 29401746Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.
PubMed 16698860Leinonen V, Vanninen R, Rauramaa T. Raised intracranial pressure and brain edema. Handb Clin Neurol. 2017;145:25-37. doi: 10.1016/B978-0-12-802395-2.00004-3.
PubMed 28987174Muballe KD, Sewani-Rusike CR, Longo-Mbenza B, Iputo J. Predictors of recovery in moderate to severe traumatic brain injury. J Neurosurg. 2018 Nov 9;131(5):1648-1657. doi: 10.3171/2018.4.JNS172185. Print 2019 Nov 1.
PubMed 30497133Li Z, Xu F, Li Y, Wang R, Zhang Z, Qu Y. Assessment of intracranial pressure monitoring in patients with moderate traumatic brain injury: A retrospective cohort study. Clin Neurol Neurosurg. 2020 Feb;189:105538. doi: 10.1016/j.clineuro.2019.105538. Epub 2019 Oct 31.
PubMed 31846845
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Observational Cohort Study of Management of Moderate Traumatic Brain Injury With or Without Intracranial Pressure Monitoring in Patients With Moderate Traumatic Brain Injury in China
- ClinicalTrials.gov ID
- NCT04900168
- Acronym / sponsor ID
- IPMMTBI / 202102-18
- Conditions
- Moderate Traumatic Brain Injury
- Keywords
- Intracranial Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 May 2021 (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.
Objectives The primary focus for scientific investigation is to conduct a multi-center observational study to determine if intracranial pressure (ICP) monitoring to direct treatment of patients with moderate traumatic brain injury (TBI) improves medical practice and patient outcomes in China.
Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. Neurologic outcome is evaluated by extended Glasgow outcome score(GOSE) at 6 months.
Interventions and Duration This is an observational study. The decision of intracranial pressure monitoring is made by the relatives of patient. Management of all patients will be consistent with protocols presently being used in the study hospitals. For patients who received ICP monitoring, the management will also be based specifically on the presence of intracranial hypertension.
Sample Size and Population Sample size calculation: Not applicable. The sample size will be equal to the total number of moderate trumatic brain injury patients consecutively admitted to hospitals during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients with moderate traumatic brain injury | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with acute moderate traumatic brain injury
Key inclusion criteria (5 listed)
- History of head trauma
- 18 ≤ age ≤ 75 years
- Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
- Glasgow coma scale at admission: 9-13
- No pregnant
Key exclusion criteria (6 listed)
- Refusing follow up visit
- Surgical treatment in other hospital before admission
- Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
- Estimated survival time less than 1 year
- Participating in other on-going clinical researches
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
Good neurologic outcome
Time frame: Within 6 months after traumatic brain injury
The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury
2 secondary outcomes
6 months mortality
Time frame: Within 6 months after traumatic brain injury
In-hospital mortality
Time frame: Within 1 month after traumatic brain injury
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 6 Nov 2026.
- Background: PubMed 26927279Godoy DA, Rubiano A, Rabinstein AA, Bullock R, Sahuquillo J. Moderate Traumatic Brain Injury: The Grey Zone of Neurotrauma. Neurocrit Care. 2016 Oct;25(2):306-19. doi: 10.1007/s12028-016-0253-y.
- Background: PubMed 25702207Hawryluk GW, Manley GT. Classification of traumatic brain injury: past, present, and future. Handb Clin Neurol. 2015;127:15-21. doi: 10.1016/B978-0-444-52892-6.00002-7.
- Background: PubMed 28504109Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
- Background: PubMed 27654000Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.
- Background: PubMed 29369057Watanitanon A, Lyons VH, Lele AV, Krishnamoorthy V, Chaikittisilpa N, Chandee T, Vavilala MS. Clinical Epidemiology of Adults With Moderate Traumatic Brain Injury. Crit Care Med. 2018 May;46(5):781-787. doi: 10.1097/CCM.0000000000002991.
- Background: PubMed 2072163Lobato RD, Rivas JJ, Gomez PA, Castaneda M, Canizal JM, Sarabia R, Cabrera A, Munoz MJ. Head-injured patients who talk and deteriorate into coma. Analysis of 211 cases studied with computerized tomography. J Neurosurg. 1991 Aug;75(2):256-61. doi: 10.3171/jns.1991.75.2.0256.
- Background: PubMed 22182868Peterson EC, Chesnut RM. Talk and die revisited: bifrontal contusions and late deterioration. J Trauma. 2011 Dec;71(6):1588-92. doi: 10.1097/TA.0b013e31822b791d.
- Background: PubMed 19197220Compagnone C, d'Avella D, Servadei F, Angileri FF, Brambilla G, Conti C, Cristofori L, Delfini R, Denaro L, Ducati A, Gaini SM, Stefini R, Tomei G, Tagliaferri F, Trincia G, Tomasello F. Patients with moderate head injury: a prospective multicenter study of 315 patients. Neurosurgery. 2009 Apr;64(4):690-6; discussion 696-7. doi: 10.1227/01.NEU.0000340796.18738.F7.
- Background: PubMed 16498188Balestreri M, Czosnyka M, Hutchinson P, Steiner LA, Hiler M, Smielewski P, Pickard JD. Impact of intracranial pressure and cerebral perfusion pressure on severe disability and mortality after head injury. Neurocrit Care. 2006;4(1):8-13. doi: 10.1385/NCC:4:1:008.
- Background: PubMed 10616075Juul N, Morris GF, Marshall SB, Marshall LF. Intracranial hypertension and cerebral perfusion pressure: influence on neurological deterioration and outcome in severe head injury. The Executive Committee of the International Selfotel Trial. J Neurosurg. 2000 Jan;92(1):1-6. doi: 10.3171/jns.2000.92.1.0001.
- Background: PubMed 29401746Harary M, Dolmans RGF, Gormley WB. Intracranial Pressure Monitoring-Review and Avenues for Development. Sensors (Basel). 2018 Feb 5;18(2):465. doi: 10.3390/s18020465.
- Background: PubMed 16698860Steiner LA, Andrews PJ. Monitoring the injured brain: ICP and CBF. Br J Anaesth. 2006 Jul;97(1):26-38. doi: 10.1093/bja/ael110. Epub 2006 May 12.
- 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.
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 Moderate Traumatic Brain Injury, run by Tang-Du 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 5 inclusion and 6 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 6 Nov 2026. 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 Zhihong Li, Doctor (+81-029-84717821, 409615390@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good neurologic outcome (time frame: Within 6 months after traumatic brain injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04900168, which also lists 15 linked publications.
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 6 Nov 2026.