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Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care (MAGMAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237819
Recruitment Status : Not yet recruiting
First Posted : August 3, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Thrombotic Thrombocytopenic Purpura Drug: Sulfate, Magnesium Drug: Placebo - Concentrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicentre double-blind randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

For each day of treatment, 4 ampoules of 10 ml will be distributed to the patient's nurse (4 ampoules of 1.5g of magnesium sulphate or 3 ampoules of 5% glucose as placebo).

The bulbs will be labeled identically so that the blind can be maintained Moreover, in order to preserve the blind, the dosage of magnesemia should not be performed outside of a necessity judged by the clinician in charge of the patient

Primary Purpose: Treatment
Official Title: Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Placebo Comparator: Placebo
Glucose serum (3 ampoules)
Drug: Placebo - Concentrate
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)
Drug: Sulfate, Magnesium

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)





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration and volume of plasma exchanges [ Time Frame: 30 days ]
  2. platelet count [ Time Frame: 5 days ]
  3. proportion of subjects with refractory TTP [ Time Frame: 5 days ]
    absence of platelet count doubling after 4 days of standard treatment

  4. Proportion of subjects with an exacerbation of TTP [ Time Frame: 30 days ]
    recurrence during the 30 days after the last daily plasma exchange

  5. Proportion of subjects with a relapse of TTP [ Time Frame: 3 months ]
    recurrence occurring more than 30 days after the last daily plasma exchange

  6. Cardiac trouble frequency [ Time Frame: day 30 ]
  7. Cerebral trouble frequency [ Time Frame: day 30 ]
  8. Acute kidney injury [ Time Frame: day 30 ]
    Kidney Disease: Improving Global Outcomes (KDIGO) score > or = 1

  9. Time to normalization of hemolysis marker levels [ Time Frame: day 30 ]
    Lactate dehydrogenase (LDH), haptoglobin, bilirubinemia, hemoglobin

  10. Hospital length of stay [ Time Frame: day 90 ]
  11. Hospital mortality [ Time Frame: day 90 ]
    90 days after randomization

  12. ICU length of stay [ Time Frame: day 90 ]
  13. ICU mortality [ Time Frame: day 90 ]
  14. Adverse events related to the use of magnesium sulfate [ Time Frame: day 7 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > or = 18 years
  • Health insurance
  • Signed inform consent by patient or relatives

Exclusion Criteria:

  • Pregnancy
  • No health insurance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237819


Contacts
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Contact: Lara ZAFRANI, MD PhD 33 1 42 49 94 21 lara.zafrani@aphp.fr

Locations
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France
Saint Louis hospital
Paris, France, 75010
Contact: Lara ZAFRANI, MD PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03237819    
Other Study ID Numbers: AOR16028
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Thrombotic Thrombocytopenic Purpura
Intensive care
Additional relevant MeSH terms:
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Membrane Transport Modulators
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Thrombophilia
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents