Clinical Trials Directory

Trials / Completed

CompletedNCT01801813

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
Phase
Study type
Observational
Enrollment
795 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
15 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2013-01-01
Primary completion
2015-11-01
Completion
2015-11-01
First posted
2013-03-01
Last updated
2017-08-11

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01801813. Inclusion in this directory is not an endorsement.