NCT03087981

Brief Summary

The PANDA trial is a multicenter prospective observational study designed to analyze various ICP derived parameters and clinical status in neurosurgical critical patients through a new big data acquisition system.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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

March 12, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 15, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

March 12, 2017

Last Update Submit

September 13, 2017

Conditions

Intracranial PressureNeurosurgeryInformation Management

Outcome Measures

Primary Outcomes (9)

  • Glasgow Outcome Scale(GOS)

    within 3 months after enrollment

  • Glasgow Coma Scale(GCS)

    within 3 months after enrollment

  • Disability Rating Scale (DRS)

    within 3 months after enrollment

  • Mean intracranial pressure(ICP) value

    throughout ICP monitoring, average 7 days

  • Correlation between pulse amplitude and mean intracranial pressure(RAP)

    throughout ICP monitoring, average 7 days

  • Pressure-reactivity index(PRx)

    throughout ICP monitoring, average 7 days

  • Pulse amplitude of ICP(AMP)

    throughout ICP monitoring, average 7 days

  • ICP-arterial blood pressure(ABP) wave amplitude correlation(IAAC)

    throughout ICP monitoring, average 7 days

  • Cerebral perfusion pressure(CPP)

    throughout ICP monitoring, average 7 days

Eligibility Criteria

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

patients with intracranial lesion

You may qualify if:

  • Age 18-65 years old
  • Intracranial lesion underwent ICP sensor implantation
  • Informed consent obtained

You may not qualify if:

  • No consent
  • A life-threatening injury to an organ other than the brain
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (5)

  • Di Ieva A, Schmitz EM, Cusimano MD. Analysis of intracranial pressure: past, present, and future. Neuroscientist. 2013 Dec;19(6):592-603. doi: 10.1177/1073858412474845. Epub 2013 Feb 6.

    PMID: 23389057BACKGROUND

  • Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10.

    PMID: 22324419BACKGROUND

  • Czosnyka M, Smielewski P, Timofeev I, Lavinio A, Guazzo E, Hutchinson P, Pickard JD. Intracranial pressure: more than a number. Neurosurg Focus. 2007 May 15;22(5):E10. doi: 10.3171/foc.2007.22.5.11.

    PMID: 17613228BACKGROUND

  • Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126.

    PMID: 15145991BACKGROUND

  • Hamilton R, Xu P, Asgari S, Kasprowicz M, Vespa P, Bergsneider M, Hu X. Forecasting intracranial pressure elevation using pulse waveform morphology. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:4331-4. doi: 10.1109/IEMBS.2009.5332749.

    PMID: 19963821BACKGROUND

Central Study Contacts

Guoyi Gao, Dr.

CONTACT

+86-021-68383709guoyigao@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2017

First Posted

March 23, 2017

Study Start

October 1, 2017

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

September 15, 2017

Record last verified: 2017-03

Locations

CN(1)