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

Completed

• Conditions: Post-operative Complications; Neuro-ICU Stay; Neuro-surgery; Brain Tumor
• Interventions: Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications

• Registration Number: NCT01801813
• Lead Sponsor: Nantes University Hospital

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-27
• Study First Posted: 2013-03-01
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-03
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 795

Inclusion Criteria

• Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria

• Neuro-surgical emergency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurosurgery for brain tumor patients	Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications	Collecting pre-operative and per-operative data, neuro-radiological data and post-operative complications

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.	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.
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France