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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01801813
Acronym
Cranioscore
Enrollment
795
Registered
2013-03-01
Start date
2013-01-31
Completion date
2015-11-30
Last updated
2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Neuro-ICU Stay, Neuro-surgery, Post-operative Complications

Keywords

Neuro-surgery, Post-operative complications, Neuro-ICU resources

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.

Interventions

OTHERCollecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing neuro-surgery for a brain tumor

Exclusion criteria

* Neuro-surgical emergency

Design outcomes

Primary

MeasureTime frame
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.During ICU stay, average of 24 hours

Secondary

MeasureTime frameDescription
Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.During ICU stay, average of 24 hoursHyponatremia \< 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 ventilationDuration of mechinal ventilation, average of 12 hours
Length of ICU stayDuration of ICU stay, average of 24 hours
Length of hospital stayDuration of hospital stay, expected average 5 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026