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NCT03237819: MAGMAT

Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care

Status unknown Phase 3 Last updated 29 October 2021
What this trial tests

Phase 3 trial testing Sulfate, Magnesium in Thrombotic Thrombocytopenic Purpura in 74 participants. Status unknown.

Timeline
27 May 2018
Primary endpoint
1 December 2021
1 December 2021

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment74
Start date27 May 2018
Primary completion1 December 2021
Estimated completion1 December 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Thrombotic Thrombocytopenic Purpura. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Thrombotic Thrombocytopenic Purpura

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

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Data sources for this page

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