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MAST - Magnesium for Sickle Cell Acute Crisis in Children

Primary Purpose

Anemia, Sickle Cell

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Magnesium Sulfate
Normal Saline
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Sickle Cell focused on measuring Anemia, Sickle Cell, Magnesium Sulfate, pediatric

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Length of stay in the hospital

Secondary Outcome Measures

Reduction mean daily pain score during an admission for sickle cell pain crisis
Adverse events during admission
Cumulative Narcotic drug required to manage the crises during admission

Full Information

First Posted
April 10, 2006
Last Updated
August 9, 2013
Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00313963
Brief Title
MAST - Magnesium for Sickle Cell Acute Crisis in Children
Official Title
MAST - Magnesium for Sickle Cell Acute Crisis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Sickle Cell
Keywords
Anemia, Sickle Cell, Magnesium Sulfate, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
Primary Outcome Measure Information:
Title
Length of stay in the hospital
Time Frame
Time frame determined by outcome
Secondary Outcome Measure Information:
Title
Reduction mean daily pain score during an admission for sickle cell pain crisis
Time Frame
Length of hospital stay
Title
Adverse events during admission
Time Frame
Length of hospital stay
Title
Cumulative Narcotic drug required to manage the crises during admission
Time Frame
Length of hospital stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Friedman, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24276838
Citation
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.
Results Reference
derived

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MAST - Magnesium for Sickle Cell Acute Crisis in Children

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