- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03237819
Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care (MAGMAT)
Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial
Thrombotic Thrombocytopenic Purpura (TTP) is a potentially life-threatening thrombotic microangiopathy caused by a severe deficiency of ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif member 13). Decreased ADAMTS13 activity leads to an accumulation of ultralarge von Willebrand factor (vWF) multimers which induce aggregation of platelets and microthrombi. These microthrombi may involve the brain, heart, kidneys and lead to life-threatening organ failures.
In experimental models, magnesium sulfate increases cleavage of newly released vWF by ADAMTS13, decreases the endothelial secretion of ultralarge vWF and inhibits the interaction of vWF with platelets. In another thrombotic microangiopathy, magnesium sulfate has been shown to reduce the risk of seizures in women with severe pre-eclampsia. In analogy with its evidence-based therapeutic application in pre-eclampsia and based on a strong rationale for magnesium supplementation in TTP, we propose a phase 3, double blind, placebo controlled, and randomized study to evaluate the efficacy of magnesium sulfate in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis in patients with Thrombotic Thrombocytopenic Purpura.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Paris, France, 75010
- Saint Louis Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > or = 18 years
- Health insurance
- Signed inform consent by patient or relatives
Exclusion Criteria:
- Pregnancy
- No health insurance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Glucose serum (3 ampoules)
|
For each day of treatment, 4 ampoules of 10 ml will be distributed to the nurse in charge of the patient (4 ampoules of glucose 5% as placebo)
|
Experimental: Magnesium Sulfate
20/5000 magnesium sulfate (4 ampoules, 1,5g each)
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Magnesium sulphate will be administered at a dose of 6g over 20 min intravenously followed by a continuous infusion of 6g / 24h for 3 days. For each day of treatment, 4 ampoules of 10 ml will be distributed to the nurse in charge of the patient (4 ampoules of 1,5g of magnesium sulfate) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to normalization of the platelet count
Time Frame: 3 months
|
Normalization of the platelet is defined as a platelet count that reaches at least 150,000 per cubic millimeter for 48 consecutive hours
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration and volume of plasma exchanges
Time Frame: 30 days
|
30 days
|
|
platelet count
Time Frame: 5 days
|
5 days
|
|
proportion of subjects with refractory TTP
Time Frame: 5 days
|
absence of platelet count doubling after 4 days of standard treatment
|
5 days
|
Proportion of subjects with an exacerbation of TTP
Time Frame: 30 days
|
recurrence during the 30 days after the last daily plasma exchange
|
30 days
|
Proportion of subjects with a relapse of TTP
Time Frame: 3 months
|
recurrence occurring more than 30 days after the last daily plasma exchange
|
3 months
|
Cardiac trouble frequency
Time Frame: day 30
|
day 30
|
|
Cerebral trouble frequency
Time Frame: day 30
|
day 30
|
|
Acute kidney injury
Time Frame: day 30
|
Kidney Disease: Improving Global Outcomes (KDIGO) score > or = 1
|
day 30
|
Time to normalization of hemolysis marker levels
Time Frame: day 30
|
Lactate dehydrogenase (LDH), haptoglobin, bilirubinemia, hemoglobin
|
day 30
|
Hospital length of stay
Time Frame: day 90
|
day 90
|
|
Hospital mortality
Time Frame: day 90
|
90 days after randomization
|
day 90
|
ICU length of stay
Time Frame: day 90
|
day 90
|
|
ICU mortality
Time Frame: day 90
|
day 90
|
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Adverse events related to the use of magnesium sulfate
Time Frame: day 7
|
day 7
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Hematologic Diseases
- Hemorrhage
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombophilia
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombotic Thrombocytopenic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- AOR16028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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