Please use this identifier to cite or link to this item: http://cris.unibe.edu.do/handle/123456789/173
DC FieldValueLanguage
dc.contributor.authorSánchez Ventura, Luisanna M.-
dc.contributor.authorUrcuyo Delgado, Gabriela-
dc.contributor.authorBergés Morales, Melissa E.-
dc.date.accessioned2021-09-23T18:42:33Z-
dc.date.available2021-09-23T18:42:33Z-
dc.date.issued2017-
dc.identifier.citationJMIR Research Protocols, 6(6), e107-
dc.identifier.urihttp://cris.unibe.edu.do/handle/123456789/173-
dc.descriptionTrial registration: ClinicalTrials.gov NCT02769845.-
dc.description.abstractBackground: In the Dominican Republic, where the burden of sickle cell anemia (SCA) is high, many children lack access to routine screening and preventative care. Children with SCA are at risk for stroke, an event that leads to significant morbidity and mortality. In the United States, screening via transcranial Doppler (TCD) identifies children with SCA at highest stroke risk, allowing early intervention with blood transfusions. The need for indefinite transfusions for primary stroke prevention limits their practicality in limited-resource countries. Hydroxyurea has been shown to lower TCD velocities and to prevent conversion from conditional (170 to 199 cm/sec) to abnormal (greater than or equal to 200 cm/sec) velocities. In resource-limited settings, implementation of a TCD screening program, coupled with hydroxyurea therapy, could reduce the burden of SCA and stroke. Objective: The aims of the Stroke Avoidance for Children in REpública Dominicana (SACRED) trial are (1) to screen children with SCA for stroke risk using TCD and to determine the prevalence of elevated velocities in a cross-sectional sample; (2) to identify clinical and laboratory correlates of elevated velocities; and (3) to obtain longitudinal data on the natural history of TCD velocities and to measure therapeutic effects of hydroxyurea. Methods: This prospective trial, designed and conducted by Cincinnati Children's Hospital Medical Center (CCHMC) and Hospital Infantil Robert Reid Cabral (HIRRC) with Centro de Obstetricia y Ginecología, includes a baseline cross-sectional epidemiological survey of the distribution of TCD velocities across a large cohort of children with SCA in the Dominican Republic. Children with conditional velocities are eligible to begin protocol-directed hydroxyurea if laboratory criteria are met. The treatment schedule begins with a fixed-dose of approximately 20 mg/kg/day for 6 months, after which it escalates to maximum tolerated dose (MTD). All participants undergo longitudinal annual TCD evaluation, while those on hydroxyurea have semi-annual evaluations during the 3-year study period. Data are collected using an Internet-based Research Electronic Data Capture (REDCap) system with forms translated into Spanish; both remote and on-site monitoring are used. Results: To date, 122 children with SCA have enrolled in SACRED including 85 (69.7%, 85/122) with normal, 29 (23.8%, 29/122) with conditional, 5 (4.1%, 5/122) with abnormal, and 3 (2.5%, 3/122) with inadequate TCD velocities. Of the 29 children with conditional TCD velocities, 17 (59%, 17/29) have initiated hydroxyurea per protocol, with plans for escalation to MTD. Conclusions: The SACRED trial will provide novel epidemiologic data about the prevalence of children with SCA and increased stroke risk in the Dominican Republic. The study also includes an investigation of the impact of hydroxyurea at MTD on elevated TCD velocities, as well as clinical and laboratory parameters. The design and implementation of SACRED reflect a successful international institutional partnership, one that features local capacity building and training in research methods and clinical care. The trial's results have important implications for screening and prevention of primary stroke in children with SCA living in resource-limited settings.en
dc.language.isoEnglish-
dc.publisherJMIR Publications Inc.-
dc.relation.ispartofJMIR Research Protocols-
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/-
dc.subjectCiencias de la Salud-
dc.titleStroke avoidance for children in República Dominicana (SACRED): Protocol for a prospective study of stroke risk and hydroxyurea treatment in sickle cell anemiaen
dc.typeJournal Article-
dc.rights.licenseThis is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.-
dc.identifier.doi10.2196/resprot.7491-
dc.identifier.pmid28576754-
dc.rights.holder© Neelum D. Jeste, Luisanna M. Sánchez, Gabriela S. Urcuyo, Melissa E. Bergés, Judy P. Luden, Susan E. Stuber, Teresa S. Latham, Rafael Mena, Rosa M. Nieves, Russell E. Ware. Originally published in JMIR Research Protocols.-
dc.contributor.affiliationFacultad de Ciencias de la Salud-
dc.contributor.affiliationFacultad de Ciencias de la Salud-
dc.contributor.affiliationFacultad de Ciencias de la Salud-
dc.identifier.pmcidPMC5473949-
dc.identifier.artnoe107-
dc.relation.issn1929-0748-
dc.description.volume6-
dc.description.issue6-
dc.subject.keywordsDominican Republicen
dc.subject.keywordsHydroxyureaen
dc.subject.keywordsSickle cell anemiaen
dc.subject.keywordsStrokeen
dc.subject.keywordsTranscranial Doppleren
dc.contributor.authorsJeste, N. D.-
dc.contributor.authorsSánchez Ventura, Luisanna M.-
dc.contributor.authorsUrcuyo Delgado, Gabriela-
dc.contributor.authorsBergés Morales, Melissa E.-
dc.contributor.authorsLuden, J. P.-
dc.contributor.authorsStuber, S. E.-
dc.contributor.authorsLatham, T. S.-
dc.contributor.authorsMena, R.-
dc.contributor.authorsNieves, R. M.-
dc.contributor.authorsWare, R. E.-
dc.typeofaccessOpen Access-
dc.contributor.affiliationinstitutionCincinnati Children's Hospital Medical Center-
dc.contributor.affiliationinstitutionUniversidad Iberoamericana (UNIBE)-
dc.contributor.affiliationinstitutionUniversidad Iberoamericana (UNIBE)-
dc.contributor.affiliationinstitutionUniversidad Iberoamericana (UNIBE)-
dc.contributor.affiliationinstitutionCincinnati Children's Hospital Medical Center-
dc.contributor.affiliationinstitutionCincinnati Children's Hospital Medical Center-
dc.contributor.affiliationinstitutionCincinnati Children's Hospital Medical Center-
dc.contributor.affiliationinstitutionCentro de Obstetricia y Ginecología-
dc.contributor.affiliationinstitutionHospital Infantil Robert Reid Cabral-
dc.contributor.affiliationinstitutionCincinnati Children's Hospital Medical Center-
dc.contributor.affiliationcountryUSA-
dc.contributor.affiliationcountryDominican Republic-
dc.contributor.affiliationcountryDominican Republic-
dc.contributor.affiliationcountryDominican Republic-
dc.contributor.affiliationcountryUSA-
dc.contributor.affiliationcountryUSA-
dc.contributor.affiliationcountryUSA-
dc.contributor.affiliationcountryDominican Republic-
dc.contributor.affiliationcountryDominican Republic-
dc.contributor.affiliationcountryUSA-
item.fulltextCon texto completo -
item.languageiso639-1English-
item.openairetypeJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.grantfulltextopen-
item.cerifentitytypePublications-
crisitem.author.deptFacultad de Ciencias de la Salud-
crisitem.author.deptFacultad de Ciencias de la Salud-
crisitem.author.deptFacultad de Ciencias de la Salud-
crisitem.author.parentorgUniversidad Iberoamericana (UNIBE)-
crisitem.author.parentorgUniversidad Iberoamericana (UNIBE)-
crisitem.author.parentorgUniversidad Iberoamericana (UNIBE)-
Appears in Collections:Publicaciones del Área de Salud - Medicina
Publicaciones indexadas en Scopus / Web of Science
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