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Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore). (Cranioscore)

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ClinicalTrials.gov Identifier: NCT01801813
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date February 15, 2013
First Posted Date March 1, 2013
Last Update Posted Date August 11, 2017
Study Start Date January 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2013)
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason. [ Time Frame: During ICU stay, average of 24 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 27, 2013)
  • Describing post-operative complications in patients undergoing neuro-surgery for brain tumor. [ Time Frame: During ICU stay, average of 24 hours ]
    Hyponatremia < 135mmol/l,Insulin administration, Nausea-Vomiting, Glasgow Coma Score, Inhalation, Post-operative intra-cranial bleeding requiring neurosurgery Intra-cranial hypertension, Use of osmotherapy, Status epilepticus, Brain death Death.
  • Duration of mechanical ventilation [ Time Frame: Duration of mechinal ventilation, average of 12 hours ]
  • Length of ICU stay [ Time Frame: Duration of ICU stay, average of 24 hours ]
  • Length of hospital stay [ Time Frame: Duration of hospital stay, expected average 5 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).
Official Title Observational Study of Risk Factors of Neuro-critical Care Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery : a Prospective Validation of the Cranioscore.
Brief Summary

Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward).

Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.

Detailed Description

Retrospective analysis of a prospective database to create a Risk Score. Post-operative neurosurgery complications recording (Hyponatremia < 135mmol/l,Insulin administration, Nausea-Vomiting, Glasgow Coma Score, Inhalation, Post-operative intra-cranial bleeding requiring neurosurgery, Intra-cranial hypertension, Use of osmotherapy, Status epilepticus, Brain death, Death).

Collection of datas as Duration of mechanical ventilation, Length of ICU stay, Length of hospital stay.

Validation of this score on an independent prospective cohort.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing neuro-surgery for a brain tumor
Condition
  • Neuro-surgery
  • Brain Tumor
  • Post-operative Complications
  • Neuro-ICU Stay
Intervention Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications
Study Groups/Cohorts Neurosurgery for brain tumor patients
Collecting pre-operative and per-operative data, neuro-radiological data and post-operative complications
Intervention: Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications
Publications * Ziai WC, Varelas PN, Zeger SL, Mirski MA, Ulatowski JA. Neurologic intensive care resource use after brain tumor surgery: an analysis of indications and alternative strategies. Crit Care Med. 2003 Dec;31(12):2782-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 24, 2016)
795
Original Estimated Enrollment
 (submitted: February 27, 2013)
800
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria:

  • Neuro-surgical emergency
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01801813
Other Study ID Numbers RC12_0416
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators
Study Chair: Karim ASEHNOUNE, PhD, MD Nantes University Hospital
PRS Account Nantes University Hospital
Verification Date March 2016