Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Other
Who is being recruted

Brain Diseases+5

+ Central Nervous System Diseases

+ Neoplasms

From 15 to 85 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2013
See protocol details

Summary

Principal SponsorNantes University Hospital
Last updated: August 11, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01801813
Principal SponsorNantes University Hospital
Last updated: August 11, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

795 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNervous System NeoplasmsCentral Nervous System NeoplasmsBrain Neoplasms

Criteria

1 inclusion criteria required to participate
Patients undergoing neuro-surgery for a brain tumor
1 exclusion criteria prevent from participating
Neuro-surgical emergency

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Nantes University Hospital

Nantes, FranceOpen Nantes University Hospital in Google Maps
CompletedOne Study Center