Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01801813
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.


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

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 795 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing neuro-surgery for a brain tumor
Criteria

Inclusion Criteria:

  • Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria:

  • Neuro-surgical emergency

Information from the National Library of Medicine

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


Locations
Layout table for location information
France
Nantes University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Study Chair: Karim ASEHNOUNE, PhD, MD Nantes University Hospital
Additional Information:

Publications:
Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01801813    
Other Study ID Numbers: RC12_0416
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: March 2016
Keywords provided by Nantes University Hospital:
Neuro-surgery
Post-operative complications
Neuro-ICU resources
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Postoperative Complications
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes