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NCT03237819: MAGMAT
Magnesium Sulfate in Thrombotic Thrombocytopenic Purpura in Intensive Care
Phase 3 trial testing Sulfate, Magnesium in Thrombotic Thrombocytopenic Purpura in 74 participants. Status unknown.
1 December 2021
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 74 |
| Start date | 27 May 2018 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Sulfate, Magnesium — full drug profile →
- Placebo - Concentrate — full drug profile →
Conditions studied
- Thrombotic Thrombocytopenic Purpura — all drugs for Thrombotic Thrombocytopenic Purpura →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Thrombotic Thrombocytopenic Purpura. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03237819
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Thrombotic Thrombocytopenic Purpura
Currently open trials in the same condition.
- NCT06727669 — Longitudinal Cohort of Thrombosis and Hemostasis Diseases · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03237819 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 29 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03237819.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing