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RecruitingNCT04900168IPMMTBIUpdated Jul 27, 2023

Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury

An observational study in Moderate Traumatic Brain Injury, sponsored by Tang-Du Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Tang-Du Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
832
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Design and Outcomes This is a prospective observational cohort multi-center study with blinded evaluation of outcome. It is a 2-group design. 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. Each patient will be evaluated at 6 months post injury on neurological outcomes.

Sample Size and Population 832 patients with moderate traumatic brain injury will be collected on this study.

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Conditions studied

  • Moderate Traumatic Brain Injury

Keywords

  • Intracranial Pressure
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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 832 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patient with acute moderate traumatic brain injury

Inclusion criteria

  • History of head trauma
  • 18 ≤ age ≤ 70 years
  • Abnormal head CT scan (skull fracture, intracranial hematoma, brain contusion, cerebral infarction, brain edema, hydrocephalus, etc.)
  • Glasgow coma scale at admission: 9-12
  • Arriving at hospital within 24 hours after injury
  • Systolic blood pressure ≥100 millimeter of mercury
  • No pregnant

Exclusion criteria

Exclusion Criteria:

  • Refusing follow up visit
  • Penetrating head injury, spine or spinal cord injury
  • Surgical treatment in other hospital before admission
  • Cardiopulmonary resuscitation after injury or in need of blood transfusion due to active bleeding
  • Consciousness disorder caused not by head trauma (alcoholism, drug overdose, etc.)
  • Prior history of head trauma or stroke
  • Multiple injuries, with severity score of other parts>18
  • Rhabdomyolysis, with blood creatine kinase (CK)>5000 international unit/L
  • Injury of aorta, carotid artery or vertebral artery
  • Serum creatinine (female)>1.2mg/dL (106μmol/L), serum creatinine (male)>1.5mg/dL (133μmol/L)
  • Glomerular filtration rate (eGFR) \<60 milliliter/min
  • Body mass index (BMI) \<18.5kg/m2 or >40kg/m2
  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
832 participants (estimated)
Patient registry
No

Groups and cohorts

  • ICP monitoring group

    patients received ICP monitoring

    Device: Intracranial pressure monitoring

  • conventional treatment group

    patients without ICP monitoring and received conventional treatment

Interventions

  • DeviceIntracranial pressure monitoring

    An invasive method to monitor the intracranial pressure of patient

06

What researchers measure

Primary outcomes

  1. Good neurologic outcome

    The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury

    Time frame: Within 6 months after traumatic brain injury

Secondary outcomes

  1. 6 months mortality

    The mortality of patients in each group at 6 months after traumatic brain injury

    Time frame: Within 6 months after traumatic brain injury

  2. In-hospital mortality

    The mortality of patients in each group during hospitalization

    Time frame: Within 1 month after traumatic brain injury

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Study locations

1 of 1 sites recruiting
  • Tangdu Hospital
    Xi'an, Shannxi Province, China
    Recruiting
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References and documents

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 26927279 ↗
  • Hawryluk 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 25702207 ↗
  • Stocchetti 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 28504109 ↗
  • Carney 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 27654000 ↗
  • Watanitanon 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 29369057 ↗
  • Lobato 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 2072163 ↗
  • Peterson 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 22182868 ↗
  • Compagnone 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 19197220 ↗
  • Balestreri 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 16498188 ↗
  • Juul 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 10616075 ↗
  • Harary 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 29401746 ↗
  • Steiner 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 16698860 ↗
  • Leinonen 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 28987174 ↗
  • Muballe 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 30497133 ↗
  • Li 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04900168
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
May 25, 2021
Start date
Jun 1, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Zhihong Li, Doctor
Contact
409615390@qq.com
+81-029-84717821

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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