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Completed

NCT Number: NCT01801813

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

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Key information

Conditions

Neuro-surgery Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neuro-ICU Stay Post-operative Complications

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing neuro-surgery for a brain tumor

Exclusion criteria

  • Neuro-surgical emergency

Treatment and study plan

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

Other

Primary outcomes

  1. Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.

    Time frame: During ICU stay, average of 24 hours

Secondary outcomes

  1. 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.

  2. Duration of mechanical ventilation

    Time frame: Duration of mechinal ventilation, average of 12 hours

  3. Length of ICU stay

    Time frame: Duration of ICU stay, average of 24 hours

  4. Length of hospital stay

    Time frame: Duration of hospital stay, expected average 5 days

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: Cranioscore

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 1, 2013
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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