Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care: Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Time to normalization of the platelet count
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
For each day of treatment, 4 ampoules of 10 ml will be distributed to the patient's nurse (4 ampoules of 1.5g of magnesium sulphate or 3 ampoules of 5% glucose as placebo).
The bulbs will be labeled identically so that the blind can be maintained Moreover, in order to preserve the blind, the dosage of magnesemia should not be performed outside of a necessity judged by the clinician in charge of the patient
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years
- •Health insurance
- •Signed inform consent by patient or relatives
排除标准
- •Pregnancy
- •No health insurance
研究组 & 干预措施
Placebo
Glucose serum (3 ampoules)
干预措施: Placebo - Concentrate (Drug)
Magnesium Sulfate
20/5000 magnesium sulfate (4 ampoules, 1,5g each)
干预措施: Sulfate, Magnesium (Drug)
结局指标
主要结局
Time to normalization of the platelet count
时间窗: 3 months
Normalization of the platelet is defined as a platelet count that reaches at least 150,000 per cubic millimeter for 48 consecutive hours
次要结局
- Duration and volume of plasma exchanges(30 days)
- proportion of subjects with refractory TTP(5 days)
- Proportion of subjects with a relapse of TTP(3 months)
- Acute kidney injury(day 30)
- Adverse events related to the use of magnesium sulfate(day 7)
- Proportion of subjects with an exacerbation of TTP(30 days)
- Hospital length of stay(day 90)
- ICU mortality(day 90)
- platelet count(5 days)
- Cerebral trouble frequency(day 30)
- Time to normalization of hemolysis marker levels(day 30)
- Hospital mortality(day 90)
- Cardiac trouble frequency(day 30)
- ICU length of stay(day 90)