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

NCT ID: NCT01801813

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

795 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-11-30

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurosurgery for brain tumor patients

Collecting pre-operative and per-operative data, neuro-radiological data and post-operative complications

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria

* Neuro-surgical emergency
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karim ASEHNOUNE, PhD, MD

Role: STUDY_CHAIR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

References

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Ziai WC, Varelas PN, Zeger SL, Mirski MA, Ulatowski JA. Neurologic intensive care resource use after brain tumor surgery: an analysis of indications and alternative strategies. Crit Care Med. 2003 Dec;31(12):2782-7. doi: 10.1097/01.CCM.0000098860.52812.24.

Reference Type BACKGROUND
PMID: 14668615 (View on PubMed)

Other Identifiers

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RC12_0416

Identifier Type: -

Identifier Source: org_study_id

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