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

Brain Tumor Clinical Trial

— Cranioscore  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801813
• Other study ID #: RC12_0416
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: August 9, 2017
• Start date: January 2013
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 795
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria:

• Neuro-surgical emergency

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Neuro-ICU Stay
• Neuro-surgery
• Post-operative Complications
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative complications requiring Neuro-ICU stay = 24 hours after surgery for neurosurgical reason.		During ICU stay, average of 24 hours
Secondary	Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.	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
Secondary	Duration of mechanical ventilation		Duration of mechinal ventilation, average of 12 hours
Secondary	Length of ICU stay		Duration of ICU stay, average of 24 hours
Secondary	Length of hospital stay		Duration of hospital stay, expected average 5 days