Neuro-surgeryCranioscoreNCT01801813
Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).
An observational study of Neuro-surgery and Brain Tumor, run by Nantes University Hospital at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Neuro-surgery, Brain Tumor, Post-operative Complications
- What is being tested?
- Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications
- How many people
- 795 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Nov 2015
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing neuro-surgery for a brain tumor
Who may be able to join
- Patients undergoing neuro-surgery for a brain tumor
Who cannot join
- Neuro-surgical emergency
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications
- Keywords
- Neuro-surgery, Post-operative complications, Neuro-ICU resources
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complicationsOther
| Study group | Role | What they receive |
|---|---|---|
| Neurosurgery for brain tumor patients | Collecting pre-operative and per-operative data, neuro-radiological data and post-operative complications Receives: Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.
Measured: During ICU stay, average of 24 hours
Secondary outcomes (4)
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.
Measured: During ICU stay, average of 24 hours
Duration of mechanical ventilation
Measured: Duration of mechinal ventilation, average of 12 hours
Length of ICU stay
Measured: Duration of ICU stay, average of 24 hours
Length of hospital stay
Measured: Duration of hospital stay, expected average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuro-surgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 795 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim ASEHNOUNE, PhD, MD, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801813
- Sponsor's protocol ID
- RC12_0416
- Acronym
- Cranioscore
- Status last verified
- Mar 2016
- First submitted
- 15 Feb 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14668615
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01801813
- Acronym / sponsor ID
- Cranioscore / RC12_0416
- Keywords
- Neuro-surgery, Post-operative complications, Neuro-ICU resources
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 795 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurosurgery for brain tumor patients | – | Other: Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complicationsCollecting pre-operative and per-operative data, neuro-radiological data and post-operative complications |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing neuro-surgery for a brain tumor
Key inclusion criteria (1 listed)
- Patients undergoing neuro-surgery for a brain tumor
Key exclusion criteria (1 listed)
- Neuro-surgical emergency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications | Other | Neurosurgery for brain tumor patients |
Primary outcome
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.
Time frame: During ICU stay, average of 24 hours
4 secondary outcomes
Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.
Time frame: During ICU stay, average of 24 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Background: PubMed 14668615Ziai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim ASEHNOUNE, PhD, MD study chair
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-surgery and Brain Tumor, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason. (time frame: During ICU stay, average of 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01801813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.