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Clinical Trials/NCT01801813
NCT01801813
Completed
Not Applicable

Observational Study of Risk Factors of Neuro-critical Care Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery : a Prospective Validation of the Cranioscore.

Nantes University Hospital1 site in 1 country795 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neuro-surgery
Sponsor
Nantes University Hospital
Enrollment
795
Locations
1
Primary Endpoint
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 2015
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria

  • Neuro-surgical emergency

Outcomes

Primary Outcomes

Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.

Time Frame: During ICU stay, average of 24 hours

Secondary Outcomes

  • Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.(During ICU stay, average of 24 hours)
  • Length of hospital stay(Duration of hospital stay, expected average 5 days)
  • Duration of mechanical ventilation(Duration of mechinal ventilation, average of 12 hours)
  • Length of ICU stay(Duration of ICU stay, average of 24 hours)

Study Sites (1)

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