Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT03237819
• Date of registration: 13/06/2017
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care MAGMAT
• Scientific title: Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial
• Date of first enrolment: May 27, 2018
• Target sample size: 74
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03237819
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age > or = 18 years

- Health insurance

- Signed inform consent by patient or relatives

Exclusion Criteria:

- Pregnancy

- No health insurance



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thrombotic Thrombocytopenic Purpura

Intervention(s)

Drug: Placebo - Concentrate

Drug: Sulfate, Magnesium

Primary Outcome(s)

Time to normalization of the platelet count [Time Frame: 3 months]

Secondary Outcome(s)

ICU mortality [Time Frame: day 90]

ICU length of stay [Time Frame: day 90]

Proportion of subjects with an exacerbation of TTP [Time Frame: 30 days]

Cerebral trouble frequency [Time Frame: day 30]

Adverse events related to the use of magnesium sulfate [Time Frame: day 7]

proportion of subjects with refractory TTP [Time Frame: 5 days]

Acute kidney injury [Time Frame: day 30]

Hospital mortality [Time Frame: day 90]

platelet count [Time Frame: 5 days]

Time to normalization of hemolysis marker levels [Time Frame: day 30]

Hospital length of stay [Time Frame: day 90]

Cardiac trouble frequency [Time Frame: day 30]

Duration and volume of plasma exchanges [Time Frame: 30 days]

Proportion of subjects with a relapse of TTP [Time Frame: 3 months]

Secondary ID(s)

AOR16028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors