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Clinical Trial
. 2011 Dec 1;57(6):1011-7.
doi: 10.1002/pbc.23145. Epub 2011 Aug 8.

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH): a phase III randomized clinical trial for treatment of children with sickle cell anemia, stroke, and iron overload

Russell E Ware  1 , William H Schultz, Nancy Yovetich, Nicole A Mortier, Ofelia Alvarez, Lee Hilliard, Rathi V Iyer, Scott T Miller, Zora R Rogers, J Paul Scott, Myron Waclawiw, Ronald W Helms
Affiliations
Clinical Trial

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH): a phase III randomized clinical trial for treatment of children with sickle cell anemia, stroke, and iron overload

Russell E Ware et al. Pediatr Blood Cancer. .

Abstract

Background: Stroke occurs in 5-10% of children with sickle cell anemia (SCA) and has a high (>50%) risk of recurrence without therapy. Chronic monthly erythrocyte transfusions effectively prevent recurrent stroke, but their long-term use is limited by serious side effects, including iron overload. An alternative to transfusion for secondary stroke prevention in SCA is needed, especially one that also improves the management of iron overload.

Methods: Stroke With Transfusions Changing to Hydroxyurea (SWiTCH) is an NHLBI-sponsored Phase III multicenter randomized controlled clinical trial for children with SCA, stroke, and iron overload (NCT00122980). The primary goal of SWiTCH is to compare 30 months of alternative therapy (hydroxyurea and phlebotomy) with standard therapy (transfusions and chelation) for the prevention of secondary stroke and reduction of transfusional iron overload.

Discussion: SWiTCH has several distinctive study features including novel methodological and design components: (1) composite primary endpoint including both stroke recurrence rate and iron burden; (2) non-inferiority design with an "acceptable" increased stroke risk; (3) transfusion goals based on current academic community practices; (4) special oversight for the enrollment and randomization process; (5) overlap treatment period within the alternative treatment arm; (6) masking of the overall trial Principal Investigator to treatment results; (7) inclusive independent stroke adjudication process for all suspected new neurological events; and (8) periodic therapeutic phlebotomy program to alleviate iron overload.

Conclusion: Investigation of alternative treatments in SWiTCH could lead to changes in the management of cerebrovascular disease for selected patients with SCA, stroke, and iron overload.

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Conflict of interest statement

No authors have conflicts to declare.

CONFLICT OF INTEREST

No author has a conflict of interest to report.

Figures

Figure 1
Figure 1
Overview of the Phase III SWiTCH randomized clinical trial (NCT00122980).
See this image and copyright information in PMC

Comment in

References

    1. Balkaran B, Char G, Morris JS, et al. Stroke in a cohort of patients with homozygous sickle cell disease. J Pediatr. 1992;120:360. - PubMed
    1. Ohene-Frempong K, Weiner SJ, Sleeper LA, et al. Cerebrovascular accidents in sickle cell disease: Rates and risk factors. Blood. 1998;91:288. - PubMed
    1. Powars D, Wilson B, Imbus C, Pegelow C, Allen J. The natural history of stroke in sickle cell disease. Am J Med. 1978;65:461. - PubMed
    1. Wilimas J, Goff JR, Anderson JR, Jr, Langston JW, Thompson E. Efficacy of transfusion therapy for one to two years in patients with sickle cell disease and cerebrovascular accidents. J Pediatr. 1980;96:205. - PubMed
    1. Wang WC, Kovnar EH, Tonkin ILe, et al. High risk of recurrent stroke after discontinuance of five to twelve years of transfusion therapy in patients with sickle cell disease. J Pediatr. 1991;118:377. - PubMed

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