Ignite Creation Date:
2024-05-06 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03237819
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2017-06-13
Brief Title:
Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Interest of Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care Multicentric Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGMAT
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None