Potential for Unblinding by Clinically Ordered Serum Magnesium Levels Clause Samples

Potential for Unblinding by Clinically Ordered Serum Magnesium Levels. In the course of ordinary clinical care of acute stroke patients, magnesium serum levels are currently variably obtained at study hospitals. The FAST-MAG Trial will allow magnesium management to follow customary care at each facility. There will not be a requirement that drawing of magnesium levels be avoided or or that all drawn magnesium levels be kept blinded and not be entered in hospital information systems. Some patients in the placebo arm may have hypomagnesemia and require supplemental therapy, and suppressing customarily drawn magnesium levels would impair their diagnosis and treatment. To ensure that key trial outcome evaluations remain unbiased, it is required that 1 month and 3 month outcome evaluations be performed by non-site FAST-MAG study nurses who have had no previous contact with the patient, the medical record, the case report form, of the treating team. This will make certain that the key outcome data for the primary endpoint and the preponderance of secondary endpoints will be obtained by fully blinded personnel.
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