NCT00886054

Brief Summary

The purpose of this study is to use transcranial Doppler (TCD) to predict intracranial pressure (ICP) and clinical outcome of neurocritical patients.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2009

Shorter than P25 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 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

April 20, 2009

Last Update Submit

December 20, 2009

Conditions

Head InjuryIntracerebral HemorrhageIschemic StrokeSubarachnoid HemorrhageBrain TumorHydrocephalus

Keywords

Transcranial DopplerTranscranial color-coded duplex sonographyNeurocritical patients

Study Arms (1)

Neurocritical patients

Neurocritical patients including those sustaining head injury, cerebrovascular events (such as intracerebral hemorrhage, subarachnoid hemorrhage, etc.), brain tumor, or hydrocephalus.

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted via emergency room for neurosurgical emergency, such as trauma, stroke, etc.

You may qualify if:

  • Aged 16 to 80 years
  • Neurocritical patient (head injury, hemorrhagic or ischemic stroke, subarachnoid hemorrhage, etc.) who was admitted to intensive care unit and had undergone intracranial pressure monitoring

You may not qualify if:

  • associated with multiple organ impairment or failure
  • single organ failure prior to neurocritical condition, such as cardiac, hepatic, or renal failure
  • associated with severe infection or sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Traumatology, National Taiwain University Hospital

Taipei, Taipei, 10002, Taiwan

Location

Related Publications (22)

  • Aaslid R, Markwalder TM, Nornes H. Noninvasive transcranial Doppler ultrasound recording of flow velocity in basal cerebral arteries. J Neurosurg. 1982 Dec;57(6):769-74. doi: 10.3171/jns.1982.57.6.0769.

    PMID: 7143059BACKGROUND

  • Berland LL, Bryan CR, Sekar BC, Moss CN. Sonographic examination of the adult brain. J Clin Ultrasound. 1988 Jun;16(5):337-45. doi: 10.1002/jcu.1870160508.

    PMID: 3152391BACKGROUND

  • Bogdahn U, Becker G, Winkler J, Greiner K, Perez J, Meurers B. Transcranial color-coded real-time sonography in adults. Stroke. 1990 Dec;21(12):1680-8. doi: 10.1161/01.str.21.12.1680.

    PMID: 2264074BACKGROUND

  • Bor-Seng-Shu E, Hirsch R, Teixeira MJ, De Andrade AF, Marino R Jr. Cerebral hemodynamic changes gauged by transcranial Doppler ultrasonography in patients with posttraumatic brain swelling treated by surgical decompression. J Neurosurg. 2006 Jan;104(1):93-100. doi: 10.3171/jns.2006.104.1.93.

    PMID: 16509152BACKGROUND

  • Baussart B, Cheisson G, Compain M, Leblanc PE, Tadie M, Benhamou D, Duranteau J. Multimodal cerebral monitoring and decompressive surgery for the treatment of severe bacterial meningitis with increased intracranial pressure. Acta Anaesthesiol Scand. 2006 Jul;50(6):762-5. doi: 10.1111/j.1399-6576.2006.01038.x.

    PMID: 16987375BACKGROUND

  • Mitchell P, Gregson BA, Vindlacheruvu RR, Mendelow AD. Surgical options in ICH including decompressive craniectomy. J Neurol Sci. 2007 Oct 15;261(1-2):89-98. doi: 10.1016/j.jns.2007.04.040. Epub 2007 Jun 4.

    PMID: 17543995BACKGROUND

  • Vahedi K, Vicaut E, Mateo J, Kurtz A, Orabi M, Guichard JP, Boutron C, Couvreur G, Rouanet F, Touze E, Guillon B, Carpentier A, Yelnik A, George B, Payen D, Bousser MG; DECIMAL Investigators. Sequential-design, multicenter, randomized, controlled trial of early decompressive craniectomy in malignant middle cerebral artery infarction (DECIMAL Trial). Stroke. 2007 Sep;38(9):2506-17. doi: 10.1161/STROKEAHA.107.485235. Epub 2007 Aug 9.

    PMID: 17690311BACKGROUND

  • Tang SC, Huang SJ, Jeng JS, Yip PK. Third ventricle midline shift due to spontaneous supratentorial intracerebral hemorrhage evaluated by transcranial color-coded sonography. J Ultrasound Med. 2006 Feb;25(2):203-9. doi: 10.7863/jum.2006.25.2.203.

    PMID: 16439783BACKGROUND

  • Schmidt B, Klingelhofer J, Schwarze JJ, Sander D, Wittich I. Noninvasive prediction of intracranial pressure curves using transcranial Doppler ultrasonography and blood pressure curves. Stroke. 1997 Dec;28(12):2465-72. doi: 10.1161/01.str.28.12.2465.

    PMID: 9412634BACKGROUND

  • McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32. doi: 10.3171/jns.1998.89.4.0526.

    PMID: 9761044BACKGROUND

  • Newell DW, Aaslid R, Stooss R, Seiler RW, Reulen HJ. Evaluation of hemodynamic responses in head injury patients with transcranial Doppler monitoring. Acta Neurochir (Wien). 1997;139(9):804-17. doi: 10.1007/BF01411398.

    PMID: 9351985BACKGROUND

  • Shiogai T, Sato E, Tokitsu M, Hara M, Takeuchi K. Transcranial Doppler monitoring in severe brain damage: relationships between intracranial haemodynamics, brain dysfunction and outcome. Neurol Res. 1990 Dec;12(4):205-13. doi: 10.1080/01616412.1990.11739944.

    PMID: 1982161BACKGROUND

  • Marti-Fabregas J, Belvis R, Guardia E, Cocho D, Munoz J, Marruecos L, Marti-Vilalta JL. Prognostic value of Pulsatility Index in acute intracerebral hemorrhage. Neurology. 2003 Oct 28;61(8):1051-6. doi: 10.1212/01.wnl.0000090520.67254.14.

    PMID: 14581663BACKGROUND

  • Bouma GJ, Muizelaar JP. Cerebral blood flow in severe clinical head injury. New Horiz. 1995 Aug;3(3):384-94.

    PMID: 7496746BACKGROUND

  • Manno EM. Transcranial Doppler ultrasonography in the neurocritical care unit. Crit Care Clin. 1997 Jan;13(1):79-104. doi: 10.1016/s0749-0704(05)70297-9.

    PMID: 9012577BACKGROUND

  • Lindegaard KF, Nornes H, Bakke SJ, Sorteberg W, Nakstad P. Cerebral vasospasm diagnosis by means of angiography and blood velocity measurements. Acta Neurochir (Wien). 1989;100(1-2):12-24. doi: 10.1007/BF01405268.

    PMID: 2683600BACKGROUND

  • Hunt WE, Hess RM. Surgical risk as related to time of intervention in the repair of intracranial aneurysms. J Neurosurg. 1968 Jan;28(1):14-20. doi: 10.3171/jns.1968.28.1.0014. No abstract available.

    PMID: 5635959BACKGROUND

  • Klingelhofer J, Dander D, Holzgraefe M, Bischoff C, Conrad B. Cerebral vasospasm evaluated by transcranial Doppler ultrasonography at different intracranial pressures. J Neurosurg. 1991 Nov;75(5):752-8. doi: 10.3171/jns.1991.75.5.0752.

    PMID: 1919698BACKGROUND

  • Wozniak MA, Sloan MA, Rothman MI, Burch CM, Rigamonti D, Permutt T, Numaguchi Y. Detection of vasospasm by transcranial Doppler sonography. The challenges of the anterior and posterior cerebral arteries. J Neuroimaging. 1996 Apr;6(2):87-93. doi: 10.1111/jon19966287.

    PMID: 8634493BACKGROUND

  • McCartney JP, Thomas-Lukes KM, Gomez CR. Introduction to Transcranial Doppler. In: Handbook of transcranial Doppler. New York: Springer-Verlag, 1997;1-13.

    RESULT

  • Baumgartner RW. Transcranial color-coded duplex sonography. J Neurol. 1999 Aug;246(8):637-47. doi: 10.1007/s004150050424.

    PMID: 10460438RESULT

  • Lindegaard K-F. Indices of pulsatility. In: Newell DW, Aaslid RA, eds. Transcranial Doppler. New York: Raven Press, 1992:67-82.

    RESULT

MeSH Terms

Conditions

Craniocerebral TraumaCerebral HemorrhageIschemic StrokeSubarachnoid HemorrhageBrain NeoplasmsHydrocephalus

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsStrokeCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Yi-Hsin Tsai, M.D.

    Department of Traumatology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

TW(1)