Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care

  • STATUS
    Recruiting
  • End date
    May 27, 2022
  • participants needed
    74
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 3 July 2021

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.

Details
Condition THROMBOTIC THROMBOCYTOPENIC PURPURA
Treatment Placebo - Concentrate, Sulfate, Magnesium
Clinical Study IdentifierNCT03237819
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on3 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Pregnancy
No health insurance
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