drugset / Trial / NCT02175225
Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
Phase 2
Completed
294 enrolled
Beth Israel Deaconess Medical Center
Columbia University · collabDuke University · collabHartford Hospital · collabHenry Ford Hospital · collabHopital de l'Enfant-Jesus · collabJohns Hopkins University · collabLoyola University · collabMassachusetts General Hospital · collabMedical University of South Carolina · collabMount Sinai Hospital, New York · collabNYU Langone Health · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabOhio State University · collabOregon Health and Science University · collabRhode Island Hospital · collabRush University Medical Center · collabSt. Joseph's Hospital and Medical Center, Phoenix · collabStanford University · collabThe University of Texas Health Science Center, Houston · collabUniversity Hospitals Cleveland Medical Center · collabUniversity of Alberta · collabUniversity of Calgary · collabUniversity of California, San Francisco · collabUniversity of Florida · collabUniversity of Iowa · collabUniversity of Massachusetts, Worcester · collabUniversity of North Carolina · collabUniversity of Pennsylvania · collabUniversity of Washington · collabWeill Medical College of Cornell University · collabYale New Haven Health System Center for Healthcare Solutions · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients with brain hemorrhage. The 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 intracerebral hemorrhage.
Timeline
- Start
- 2014-10
- Primary completion
- 2018-02-10
- Completion
- 2018-05-30
Outcome
Missed primary endpoint
paper 48 (34%) of 140 participants in the deferoxamine mesylate group, and 47 (33%) of 143 patients in the placebo group PMID 30898550 ↗
paper adjusted absolute risk difference 0·6% [90% upper confidence bound 6·8%]. PMID 30898550 ↗
paper would be futile. PMID 30898550 ↗
Publications
- Background 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.
- 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 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 Hatakeyama T, Okauchi M, Hua Y, Keep RF, Xi G. Deferoxamine reduces neuronal death and hematoma lysis after intracerebral hemorrhage in aged rats. Transl Stroke Res. 2013 Oct;4(5):546-53. doi: 10.1007/s12975-013-0270-5.
- Background Xie Q, Gu Y, Hua Y, Liu W, Keep RF, Xi G. Deferoxamine attenuates white matter injury in a piglet intracerebral hemorrhage model. Stroke. 2014 Jan;45(1):290-2. doi: 10.1161/STROKEAHA.113.003033. Epub 2013 Oct 30.
- Background Okauchi M, Hua Y, Keep RF, Morgenstern LB, Schallert T, Xi G. Deferoxamine treatment for intracerebral hemorrhage in aged rats: therapeutic time window and optimal duration. Stroke. 2010 Feb;41(2):375-82. doi: 10.1161/STROKEAHA.109.569830. Epub 2009 Dec 31.
- Background Sonni S, Lioutas VA, Selim MH. New avenues for treatment of intracranial hemorrhage. Curr Treat Options Cardiovasc Med. 2014 Jan;16(1):277. doi: 10.1007/s11936-013-0277-y.
- Polymeris AA, Lioutas VA, Incontri D, Soman S, Selim MH; i-DEF Investigators. Evolution of Perihematomal Edema Mean Hounsfield Unit and Its Association with Clinical Outcome in Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Neurocrit Care. 2025 Dec;43(3):824-833. doi: 10.1007/s12028-025-02337-7. Epub 2025 Aug 11.
- Polymeris AA, Lioutas VA, Foster LD, Incontri D, Heistand EC, Marchal J, Lazar A, Fischer U, Engelter ST, Seiffge DJ, Yeatts SD, Selim MH. Early neurological improvement with deferoxamine after intracerebral hemorrhage: A post hoc analysis of the i-DEF trial. Int J Stroke. 2025 Dec;20(10):1235-1245. doi: 10.1177/17474930251348088. Epub 2025 May 26.
- Polymeris AA, Lioutas VA, Marchina S, Seiffge DJ, Roh DJ, Poyraz FC, Selim MH; i-DEF Investigators. Hemoglobin and Perihematomal Edema After Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Neurocrit Care. 2026 Feb;44(1):64-71. doi: 10.1007/s12028-025-02284-3. Epub 2025 May 21.
- Lee KH, Lioutas VA, Marchina S, Selim M; iDEF Investigators. The Prognostic Roles of Perihematomal Edema and Ventricular Size in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2022 Oct;37(2):455-462. doi: 10.1007/s12028-022-01532-0. Epub 2022 Jun 8.
- Foster L, Robinson L, Yeatts SD, Conwit RA, Shehadah A, Lioutas V, Selim M; i-DEF Investigators. Effect of Deferoxamine on Trajectory of Recovery After Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Stroke. 2022 Jul;53(7):2204-2210. doi: 10.1161/STROKEAHA.121.037298. Epub 2022 Mar 21.
- Wei C, Wang J, Foster LD, Yeatts SD, Moy C, Mocco J, Selim M; i-DEF Investigators. Effect of Deferoxamine on Outcome According to Baseline Hematoma Volume: A Post Hoc Analysis of the i-DEF Trial. Stroke. 2022 Apr;53(4):1149-1156. doi: 10.1161/STROKEAHA.121.035421. Epub 2021 Nov 18.
- Lun R, Yogendrakumar V, Ramsay T, Shamy M, Fahed R, Selim MH, Dowlatshahi D. Predicting long-term outcomes in acute intracerebral haemorrhage using delayed prognostication scores. Stroke Vasc Neurol. 2021 Dec;6(4):536-541. doi: 10.1136/svn-2020-000656. Epub 2021 Mar 23.
- Selim M, Foster LD, Moy CS, Xi G, Hill MD, Morgenstern LB, Greenberg SM, James ML, Singh V, Clark WM, Norton C, Palesch YY, Yeatts SD; i-DEF Investigators. Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2019 May;18(5):428-438. doi: 10.1016/S1474-4422(19)30069-9. Epub 2019 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deferoxamine | Other / unclassified | 32 mg/kg | Intravenous |