Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury (IPMMTBI)

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. 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.

Study Overview

• Status: Recruiting
• Conditions: Moderate Traumatic Brain Injury
• Intervention / Treatment: Device: Intracranial pressure monitoring

• Study Type: Observational
• Enrollment (Estimated): 832

Contacts and Locations

• Study Contact: Name: Zhihong Li, Doctor; Phone Number: +81-029-84717821; Email: 409615390@qq.com

Study Locations

• China
  • Shannxi Province
    • Xi'an, Shannxi Province, China
      • Recruiting
      • Tangdu Hospital
      • Contact: Zhihong Li; Phone Number: +86-13709183909; Email: 409615390@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patient with acute moderate traumatic brain injury

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICP monitoring group; patients received ICP monitoring	Device: Intracranial pressure monitoring; An invasive method to monitor the intracranial pressure of patient
conventional treatment group; patients without ICP monitoring and received conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Good neurologic outcome	The proportion of patients with good neurological outcomes (GOSE: 5-8) in each group at 6 months after traumatic brain injury	Within 6 months after traumatic brain injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 months mortality	The mortality of patients in each group at 6 months after traumatic brain injury	Within 6 months after traumatic brain injury
In-hospital mortality	The mortality of patients in each group during hospitalization	Within 1 month after traumatic brain injury

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Muballe KD, Sewani-Rusike CR, Longo-Mbenza B, Iputo J. Predictors of recovery in moderate to severe traumatic brain injury. J Neurosurg. 2018 Nov 1:1-10. doi: 10.3171/2018.4.JNS172185. Online ahead of print.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: May 23, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Intracranial Pressure
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 202102-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes