Seizures (Incl Subtypes)Phase 3MAGNANCT01601314
Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
A Phase 3 study testing Magnesium Sulfate and Sodium Chloride in people with Seizures (Incl Subtypes) and Brain Tumor, run by Sara Varea at 1 site in Spain.
Trial summary
The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Seizures (Incl Subtypes), Brain Tumor
- What is being tested?
- Magnesium Sulfate and Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2012to Dec 2017
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females older than 18 years.
- Undergoing supratentorial parenchyma resection surgery.
- Capable of collaborate on probes and explorations included in the study.
- Signature the written informed consent form.
Who cannot join
- Life expectancy less than 12 months due to the suspected histological type of tumour.
- Hypothalamic-pituitary axis illness.
- Presence of Melanoma previously.
- Glomerular filtration rate less than 60 mL/min.
- Thyroid or parathyroid glands pathology.
- Myasthenia gravis.
- Respiratory depression.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.
- Conditions
- Seizures (Incl Subtypes), Brain Tumor
- Being tested
- Magnesium Sulfate, Sodium Chloride
- Medical subject headings
- Seizures, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
At the beginning of the neurosurgery, the subjects are going to receive one 4gr bolus in Sodium Chloride 100 mL, lasting 20 minutes, intravenously.
After that, a intravenously perfusion of Magnesium Sulfate 20 gr, in Sodium Chloride 1000 mL, lasting 24 hours, will be started.
Sodium ChlorideOther
At the beginning of the neurosurgery, the subjects are going to receive a bolus of Sodium Chloride 100 mL, lasting 20 minutes, intravenously.
After that, a intravenously perfusion of Sodium Chloride 1000 mL, lasting 24 hours, will be started.
| Study group | Role | What they receive |
|---|---|---|
| magnesium sulphate | Experimental | The patients who are going to receive Magnesium Sulphate Receives: Drug: Magnesium Sulfate |
| Control | Placebo comparator | Patients who are going to receive Sodium Chloride 0.9% Receives: Other: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum S100B protein
Measured: 2 hours after the end of the surgery
Secondary outcomes (7)
Serum S100B protein
Measured: 1 hour before surgery; daily postoperative until day 10.
Serum Specific Neuronal Enolase (SNE)
Measured: 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10
Improvement on Magnetic Resonance Imaging
Measured: within the month prior to surgery; early postoperative; 6 months postoperative
Improvement on Neuropsychological Assessment
Measured: within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative
Glasgow Outcome Scale
Measured: 6 and 12 month postoperative
Mortality
Measured: 6 and 12 month postoperative
Apolipoprotein E genotype
Measured: 1 hour before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seizures (Incl Subtypes)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Neus Fabregas, MD PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601314
- Sponsor's protocol ID
- MAGNA
- Other IDs
- 2011-006301-10
- Acronym
- MAGNA
- Status last verified
- Jan 2018
- First submitted
- 10 May 2012
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Magnesium Sulphate as a Cerebral Protector in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT01601314
- Acronym / sponsor ID
- MAGNA / MAGNA
- Conditions
- Seizures (Incl Subtypes), Brain Tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 May 2012 (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.
The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium sulphate | Experimental | Drug: Magnesium SulfateThe patients who are going to receive Magnesium Sulphate |
| Control | Placebo comparator | Other: Sodium ChloridePatients who are going to receive Sodium Chloride 0.9% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and females older than 18 years.
- Undergoing supratentorial parenchyma resection surgery.
- Capable of collaborate on probes and explorations included in the study.
- Signature the written informed consent form.
Key exclusion criteria (8 listed)
- Life expectancy less than 12 months due to the suspected histological type of tumour.
- Hypothalamic-pituitary axis illness.
- Presence of Melanoma previously.
- Glomerular filtration rate less than 60 mL/min.
- Thyroid or parathyroid glands pathology.
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 |
|---|---|---|
| Magnesium SulfateAt the beginning of the neurosurgery, the subjects are going to receive one 4gr bolus in Sodium Chloride 100 mL, lasting 20 minutes, intravenously. After that, a intravenously perfusion of Magnesium Sulfate 20 gr, in Sodium Chloride 1000 mL, lasting 24 hours, will be started. | Drug | magnesium sulphate |
| Sodium ChlorideAt the beginning of the neurosurgery, the subjects are going to receive a bolus of Sodium Chloride 100 mL, lasting 20 minutes, intravenously. After that, a intravenously perfusion of Sodium Chloride 1000 mL, lasting 24 hours, will be started. | Other | Control |
Primary outcome
Serum S100B protein
Time frame: 2 hours after the end of the surgery
7 secondary outcomes
Serum S100B protein
Time frame: 1 hour before surgery; daily postoperative until day 10.
Serum Specific Neuronal Enolase (SNE)
Time frame: 1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10
Improvement on Magnetic Resonance Imaging
Time frame: within the month prior to surgery; early postoperative; 6 months postoperative
Improvement on Neuropsychological Assessment
Time frame: within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative
Glasgow Outcome Scale
Time frame: 6 and 12 month postoperative
Mortality
Time frame: 6 and 12 month postoperative
Apolipoprotein E genotype
Time frame: 1 hour before surgery
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 17 Jan 2018.
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.
Neus Fabregas, MD PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Sulfate and Sodium Chloride in people with Seizures (Incl Subtypes) and Brain Tumor, run by Sara Varea at 1 site in Spain.
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 4 inclusion and 8 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 17 Jan 2018. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum S100B protein (time frame: 2 hours after the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2018.