Anemia, Sickle CellPhase 3NCT00313963
MAST - Magnesium for Sickle Cell Acute Crisis in Children
A Phase 3 study testing Magnesium Sulfate and Normal Saline in people with Anemia, Sickle Cell, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- Magnesium Sulfate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Jul 2013
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Known sickle cell disease
- Previous painful crisis resulting in an Emergency Department(ED) visit
- Current visit with a chief complaint of pain
- Age 4 years - 18 years
- Staff ED decides to admit to the hospital
- Staff ED decides to start an intravenous line
Who cannot join
- Fever (>38.5C) during the 24 hours prior to visit at triage
- Patients transfused within 90 days of study entry
- Patients with known renal disease
- Patients with known heart block or myocardial damage
- Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
- Patients who received anesthetics, cardiac glycosides and neuromuscular blockers during the acute illness in the last 24 hours
Show all 11Show fewer
- Patients or parents unable to communicate in English
- Known pregnancy
- Known allergy to Magnesium
- Admission to the ICU
- Enrolment to the study in the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.
Read the detailed description
Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.
In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.
- Conditions
- Anemia, Sickle Cell
- Being tested
- Magnesium Sulfate, Normal Saline
- Keywords
- Anemia, Sickle Cell, Magnesium Sulfate, pediatric
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
Normal SalineDrug
Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Magnesium Sulfate |
| 2 | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the hospital
Measured: Time frame determined by outcome
Secondary outcomes (3)
Reduction mean daily pain score during an admission for sickle cell pain crisis
Measured: Length of hospital stay
Adverse events during admission
Measured: Length of hospital stay
Cumulative Narcotic drug required to manage the crises during admission
Measured: Length of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2008
- Study completionJul 2013
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 Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Jeremy Friedman, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313963
- Sponsor's protocol ID
- 1000008367
- Status last verified
- Aug 2013
- First submitted
- 10 Apr 2006
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goldman RD, Mounstephen W, Kirby-Allen M, Friedman JN. Intravenous magnesium sulfate for vaso-occlusive episodes in sickle cell disease. Pediatrics. 2013 Dec;132(6):e1634-41. doi: 10.1542/peds.2013-2065. Epub 2013 Nov 25.
PubMed 24276838
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAST - Magnesium for Sickle Cell Acute Crisis in Children
- ClinicalTrials.gov ID
- NCT00313963
- Acronym / sponsor ID
- 1000008367
- Conditions
- Anemia, Sickle Cell
- Keywords
- Anemia, Sickle Cell, Magnesium Sulfate, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Apr 2006 (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 if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.
Detailed description
Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis, acute vaso-occlusive episodes (crises), unpredictable acute complications that can be life-threatening, and the variable development of chronic organ damage. Administration of magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged chloride ions and water entry to the cell. To date only one non-randomized, non-blinded, single arm study with only 19 children evaluated the effect of magnesium on length of stay in the hospital of children with sickle cell disease.
In this randomized, double blind, two-arm placebo controlled study, children with sickle cell disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or placebo every 8 hours during their stay in the hospital , along with pain management. We will measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics required for pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Magnesium Sulfate |
| 2 | Placebo comparator | Drug: Normal Saline |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Known sickle cell disease
- Previous painful crisis resulting in an Emergency Department(ED) visit
- Current visit with a chief complaint of pain
- Age 4 years - 18 years
- Staff ED decides to admit to the hospital
Key exclusion criteria (11 listed)
- Fever (>38.5C) during the 24 hours prior to visit at triage
- Patients transfused within 90 days of study entry
- Patients with known renal disease
- Patients with known heart block or myocardial damage
- Patients who take a magnesium-containing medication or calcium channel blocker on a regular basis
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 SulfateIntravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly. | Drug | 1 |
| Normal SalineIntravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly. | Drug | 2 |
Primary outcome
Length of stay in the hospital
Time frame: Time frame determined by outcome
3 secondary outcomes
Reduction mean daily pain score during an admission for sickle cell pain crisis
Time frame: Length of hospital stay
Adverse events during admission
Time frame: Length of hospital stay
Cumulative Narcotic drug required to manage the crises during admission
Time frame: Length of hospital stay
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 13 Aug 2013.
- Derived from this study: PubMed 24276838Goldman RD, Mounstephen W, Kirby-Allen M, Friedman JN. Intravenous magnesium sulfate for vaso-occlusive episodes in sickle cell disease. Pediatrics. 2013 Dec;132(6):e1634-41. doi: 10.1542/peds.2013-2065. Epub 2013 Nov 25.
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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.
Jeremy Friedman, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 Normal Saline in people with Anemia, Sickle Cell, run by The Hospital for Sick Children at 1 site in Canada.
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 6 inclusion and 11 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 13 Aug 2013. 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 Canada. 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?
Length of stay in the hospital (time frame: Time frame determined by outcome). 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 NCT00313963, 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 13 Aug 2013.