MAST - Magnesium for Sickle Cell Acute Crisis in Children | NCT00313963

Studies
MAST - Magnesium for Sickle Cell Acute Crisis in Children

NCT00313963

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Aug 13, 2013Estimated

Enrollment

120Actual

Phase

Phase 3

Conditions

Anemia, Sickle Cell

Interventions

Magnesium Sulfate
Normal Saline

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Jul 2013Actual

First Submitted Date

Apr 10, 2006

First Submission Date that Met QC Criteria

Apr 10, 2006

First Posted Date

Apr 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2013

Last Update Posted Date

Aug 13, 2013Estimated

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Magnesium Sulfate
2	Placebo Comparator		Drug: Normal Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug	Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay in the hospital		Time frame determined by outcome

Secondary Outcomes

Measure	Description	Time Frame
Reduction mean daily pain score during an admission for sickle cell pain crisis		Length of hospital stay
Adverse events during admission		Length of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy Friedman, MD	The Hospital for Sick Children, Toronto Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24276838	Derived	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.

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

ID	Term
D008278	Magnesium Sulfate
D000077330	Saline Solution

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids