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

August 9, 2017 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

795

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing neuro-surgery for a brain tumor

Description

Inclusion Criteria:

  • Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria:

  • Neuro-surgical emergency

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neurosurgery for brain tumor patients
Collecting pre-operative and per-operative data, neuro-radiological data and post-operative complications
Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.
Time Frame: During ICU stay, average of 24 hours
During ICU stay, average of 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.
Time Frame: 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.
During ICU stay, average of 24 hours
Duration of mechanical ventilation
Time Frame: Duration of mechinal ventilation, average of 12 hours
Duration of mechinal ventilation, average of 12 hours
Length of ICU stay
Time Frame: Duration of ICU stay, average of 24 hours
Duration of ICU stay, average of 24 hours
Length of hospital stay
Time Frame: Duration of hospital stay, expected average 5 days
Duration of hospital stay, expected average 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Study Chair: Karim ASEHNOUNE, PhD, MD, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (ESTIMATE)

March 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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