drugset / Trial / NCT01662895
High-Dose Deferoxamine in Intracerebral Hemorrhage
Phase 2
Terminated
42 enrolled
Beth Israel Deaconess Medical Center
Dalhousie University · collabDuke University · collabHartford Hospital · collabHenry Ford Hospital · collabHopital de l'Enfant-Jesus · collabJohns Hopkins University · collabMassachusetts General Hospital · collabMedical University of South Carolina · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabOhio State University · collabOregon Health and Science University · collabRhode Island Hospital · collabSt. Joseph's Hospital and Medical Center, Phoenix · collabStanford University · collabThe Cleveland Clinic · collabThe University of Texas Health Science Center, Houston · collabTufts Medical Center · collabUniversity of Alberta · collabUniversity of Calgary · collabUniversity of California, San Francisco · collabUniversity of Florida · collabUniversity of Iowa · collabUniversity of Maryland · collabUniversity of Massachusetts, Worcester · collabUniversity of North Carolina · collabUniversity of Pennsylvania · collabUniversity of Virginia · collabUniversity of Washington · collabYale New Haven Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main purpose of this study is to determine whether treatment with deferoxamine mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for brain hemorrhage.
Timeline
- Start
- 2013-03-18
- Primary completion
- 2014-01-15
- Completion
- 2018-05-10
Outcome
Outcome not reported
Stopped: “By DSMB on October 18, 2013 due to increased incidence of ARDS. See modified protocol \[NCT02175225”
Publications
- Background Selim M. Deferoxamine mesylate: a new hope for intracerebral hemorrhage: from bench to clinical trials. Stroke. 2009 Mar;40(3 Suppl):S90-1. doi: 10.1161/STROKEAHA.108.533125. Epub 2008 Dec 8.
- Background Selim M, Yeatts S, Goldstein JN, Gomes J, Greenberg S, Morgenstern LB, Schlaug G, Torbey M, Waldman B, Xi G, Palesch Y; Deferoxamine Mesylate in Intracerebral Hemorrhage Investigators. Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage. Stroke. 2011 Nov;42(11):3067-74. doi: 10.1161/STROKEAHA.111.617589. Epub 2011 Aug 25.
- Background Gu Y, Hua Y, Keep RF, Morgenstern LB, Xi G. Deferoxamine reduces intracerebral hematoma-induced iron accumulation and neuronal death in piglets. Stroke. 2009 Jun;40(6):2241-3. doi: 10.1161/STROKEAHA.108.539536. Epub 2009 Apr 16.
- Background Okauchi M, Hua Y, Keep RF, Morgenstern LB, Xi G. Effects of deferoxamine on intracerebral hemorrhage-induced brain injury in aged rats. Stroke. 2009 May;40(5):1858-63. doi: 10.1161/STROKEAHA.108.535765. Epub 2009 Mar 12.
- Roh DJ, Poyraz FC, Mao E, Shen Q, Kansara V, Cottarelli A, Song S, Nemkov T, Kumar A, Hudson KE, Ghoshal S, Park S, Agarwal S, Connolly ES, Claassen J, Kreuziger LB, Hod E, Yeatts S, Foster LD, Selim M. Anemia From Inflammation After Intracerebral Hemorrhage and Relationships With Outcome. J Am Heart Assoc. 2024 Jul 16;13(14):e035524. doi: 10.1161/JAHA.124.035524. Epub 2024 Jul 9.
- Yeatts SD, Palesch YY, Moy CS, Selim M. High dose deferoxamine in intracerebral hemorrhage (HI-DEF) trial: rationale, design, and methods. Neurocrit Care. 2013 Oct;19(2):257-66. doi: 10.1007/s12028-013-9861-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Deferoxamine | Other / unclassified | 62 mg/kg | Intravenous |