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Intensive care medicine · Nov 2023
Randomized Controlled Trial Multicenter StudyMagnesium sulphate in patients with thrombotic thrombocytopenic purpura (MAGMAT): a randomised, double-blind, superiority trial.
- Lara Zafrani, Emmanuel Canet, Anouk Walter-Petrich, Bérangère Joly-Laffargue, Agnès Veyradier, Stanislas Faguer, Naïke Bigé, Laure Calvet, Julien Mayaux, Steven Grangé, Cédric Rafat, Coralie Poulain, Kada Klouche, Pierre Perez, Frédéric Pène, Claire Pichereau, Baptiste Duceau, Eric Mariotte, Sylvie Chevret, and Elie Azoulay.
- Department of Medical Intensive Care Unit, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris Cité, Paris, France. lara.zafrani@aphp.fr.
- Intensive Care Med. 2023 Nov 1; 49 (11): 129313041293-1304.
PurposeStudies have suggested benefits from magnesium sulphate in thrombotic thrombocytopenic purpura (TTP). We aimed to measure the effects of magnesium sulphate supplementation on TTP recovery.MethodsIn this multicenter, randomised, double-blind, controlled, superiority study, we enrolled adults with a clinical diagnosis of TTP. Patients were randomly allocated to receive magnesium sulphate (6 g intravenously followed by a continuous infusion of 6 g/24 h for 3 days) or placebo, in addition to the standard treatment. The primary outcome was the median time to platelet normalisation (defined as a platelet count ≥ 150 G/L). Efficacy and safety were assessed by intention-to-treat.ResultsOverall, we enrolled 74 participants, including one who withdrew his/her consent. Seventy-three patients were further analyzed, 35 (48%) allocated to magnesium sulphate and 38 (52%) to placebo. The median time to platelet normalisation was 4 days (95% confidence interval [CI], 3-4) in the magnesium sulphate group and 4 days (95% CI 3-5) in the placebo group. The cause-specific hazard ratio of response was 0.93 (95% CI 0.58-1.48, p = 0.75). The number of patients with ≥ 1 serious adverse reactions was similar in the two groups. By day 90, four patients in the magnesium sulphate group and two patients in the placebo group had died (p = 0.42). The most frequent adverse event was low blood pressure occurring in 34% in the magnesium sulphate group and 29% in the placebo group (p = 0.80).ConclusionAmong patients with TTP, the addition of magnesium sulphate to the standard of care did not result in a significant improvement in time to platelet normalisation.© 2023. Springer-Verlag GmbH Germany, part of Springer Nature.
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