Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore). (Cranioscore)
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|ClinicalTrials.gov Identifier: NCT01801813|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : August 11, 2017
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.
|Condition or disease||Intervention/treatment|
|Neuro-surgery Brain Tumor Post-operative Complications Neuro-ICU Stay||Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications|
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 [Patient Registry]|
|Actual Enrollment :||795 participants|
|Target Follow-Up Duration:||2 Months|
|Official Title:||Observational Study of Risk Factors of Neuro-critical Care Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery : a Prospective Validation of the Cranioscore.|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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
- Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason. [ Time Frame: During ICU stay, average of 24 hours ]
- 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.
- Duration of mechanical ventilation [ Time Frame: Duration of mechinal ventilation, average of 12 hours ]
- Length of ICU stay [ Time Frame: Duration of ICU stay, average of 24 hours ]
- Length of hospital stay [ Time Frame: Duration of hospital stay, expected average 5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801813
|Nantes University Hospital|
|Nantes, France, 44000|
|Study Chair:||Karim ASEHNOUNE, PhD, MD||Nantes University Hospital|