NCT04900168

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
832

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.6 years

First QC Date

April 7, 2021

Last Update Submit

July 25, 2023

Conditions

Moderate Traumatic Brain Injury

Keywords

Intracranial Pressure

Outcome Measures

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

    Within 6 months after traumatic brain injury

Secondary Outcomes (2)

  • 6 months mortality

    Within 6 months after traumatic brain injury

  • In-hospital mortality

    Within 1 month after traumatic brain injury

Study Arms (2)

ICP monitoring group

patients received ICP monitoring

Device: Intracranial pressure monitoring

conventional treatment group

patients without ICP monitoring and received conventional treatment

Interventions

Intracranial pressure monitoringDEVICE

An invasive method to monitor the intracranial pressure of patient

ICP monitoring group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient with acute moderate traumatic brain injury

You may qualify if:

  • History of head trauma
  • ≤ 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shannxi Province, China

RECRUITING

Related Publications (15)

  • 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.

    PMID: 26927279BACKGROUND

  • 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.

    PMID: 25702207BACKGROUND

  • 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.

    PMID: 28504109BACKGROUND

  • 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.

    PMID: 27654000BACKGROUND

  • 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.

    PMID: 29369057BACKGROUND

  • 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.

    PMID: 2072163BACKGROUND

  • 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.

    PMID: 22182868BACKGROUND

  • 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.

    PMID: 19197220BACKGROUND

  • 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.

    PMID: 16498188BACKGROUND

  • 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.

    PMID: 10616075BACKGROUND

  • 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.

    PMID: 29401746BACKGROUND

  • 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.

    PMID: 16698860BACKGROUND

  • 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.

    PMID: 28987174BACKGROUND

  • 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.

    PMID: 30497133BACKGROUND

  • 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.

    PMID: 31846845BACKGROUND

Central Study Contacts

Zhihong Li, Doctor

CONTACT

+81-029-84717821409615390@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

May 25, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

CN(1)