- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00951808
Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)
Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
SCD is an inherited blood disorder, and symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." ACS, characterized by fever, respiratory distress, and lung tissue damage, is the second most common cause of hospitalization and the leading cause of death among people with SCD. Most people with SCD will experience at least one episode of ACS, and repeated episodes can result in progressive lung disease. ACS can appear suddenly and often requires immediate hospitalization and treatment, which can include blood transfusions. People with elevated blood levels of sPLA2 may be at risk for developing ACS, and this enzyme is often detectable before the onset of ACS symptoms. The purpose of this study is to examine the use of sPLA2 as a predictor of ACS and to determine whether subsequent blood transfusions can be administered early enough to prevent the onset of ACS in people with SCD who are at risk for ACS. Study researchers will also assess the feasibility of conducting a larger study that would further examine the effectiveness of using sPLA2 levels and blood transfusions to prevent ACS.
This study will involve two parts. In the first part of the study, participants with SCD who are admitted to the hospital with an acute sickle cell pain event will be randomly assigned to receive either a single blood transfusion or standard care for ACS and no blood transfusion. All participants will be closely monitored while in the hospital for the development of ACS, and study researchers will review participants' medical records. All participants will undergo daily blood collections, which will include testing for sPLA2 levels, and at least two chest x-rays. Twenty-eight days after hospital discharge, all participants will attend a follow-up study visit for blood collection, again to determine sPLA2 levels.
In the second part of the study, participants who are not eligible or who do not choose to participate in the first part of the study will be enrolled into an observational group. These participants will receive standard care for ACS, but will not receive a blood transfusion. They will undergo daily blood collection during their hospital stay and at least one chest x-ray. While participants are in the hospital and 28 days after discharge, study researchers will review participants' medical records.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Oakland, California, Estados Unidos
- Children's Hospital and Research Center
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Delaware
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Wilmington, Delaware, Estados Unidos
- A.I. Dupont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Estados Unidos
- Children's National Medical Center
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Washington, District of Columbia, Estados Unidos
- Howard University Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos
- Emory University School of Medicine
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Augusta, Georgia, Estados Unidos
- Medical College of Georgia
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Illinois
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Chicago, Illinois, Estados Unidos
- Children's Memorial Hospital
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Chicago, Illinois, Estados Unidos
- University of Illinois Sickle Cell Center
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Kentucky
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Louisville, Kentucky, Estados Unidos
- Kosair Children's Hospital
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Maryland
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Baltimore, Maryland, Estados Unidos
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Estados Unidos
- Children's Hospital Boston
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Boston,, Massachusetts, Estados Unidos
- Boston Medical Center
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Boston,, Massachusetts, Estados Unidos
- Brigham & Women's Hospital
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Mississippi
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Jackson, Mississippi, Estados Unidos
- University of Mississippi Medical Center
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New York
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Brooklyn, New York, Estados Unidos
- Interfaith Medical Center
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Brooklyn, New York, Estados Unidos
- New York Methodist Hospital
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos
- The University of North Carolina at Chapel Hill
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Durham, North Carolina, Estados Unidos
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Estados Unidos
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, Estados Unidos
- Ohio State University
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Columbus, Ohio, Estados Unidos
- Nationwide Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Estados Unidos
- St. Christopher's Hospital for Children
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Virginia
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Richmond, Virginia, Estados Unidos
- Virginia Commonwealth University Health Systems
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria for the Observational and Trial Cohorts:
- Hemoglobin diagnosis of SS (two copies of the hemoglobin S gene), SC (one copy of the hemoglobin S gene and one copy of the hemoglobin C gene), or S-β thalassemia (β+ or β0)
- No clinically apparent ACS
- No prior participation in either part of the study
Inclusion Criteria for the Trial Cohort, in addition to the above criteria:
- sPLA2 level greater than 100 ng/mL within the same 24-hour window that coincides with fever and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window
- Fever greater than 38.0º C within the same 24-hour window that coincides with elevated sPLA2 level (greater than 100 ng/mL) and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window
- Chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window of an abnormal sPLA2 level and fever
- Hemoglobin levels equal or less than 10 g/dL at time of study entry
- Informed consent of parent(s) or legal guardian; informed consent or assent of participant as applicable
Exclusion Criteria for Observational and Trial Cohorts:
- Existing diagnosis of a new pulmonary infiltrate diagnosed by chest radiography (pleural effusion not obscuring lung parenchyma will not exclude the person from the study)
- Any coexisting medical condition for which the physician feels that a transfusion may be needed within 24 hours (e.g., severe anemia, stroke)
- Red Blood Cell (RBC) transfusion in the 60 days before study entry
- Unwillingness to sign consent form, or if a minor, unwillingness of parent/guardian to sign consent form
- Treatment with any investigational drug or device in the 30 days before study entry (hydroxyurea is allowable)
- History of alloimmunization that would prevent the participant from receiving blood within 8 hours of eligibility for study entry or history of a life-threatening transfusion reaction
- Objection to transfusion for religious or other reasons from either the participant or guardian
- History of treatment with systemic steroids within 1 week of study entry (inhaled steroids are acceptable)
- Pregnant
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Blood Transfusion Trial Cohort
Twenty participants will receive a blood transfusion while in the hospital.
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Participants will receive a single transfusion of 7-13cc/kg packed red blood cells (RBCs) while in the hospital.
Outros nomes:
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Comparador Ativo: Standard Care Trial Cohort
Twenty participants will not receive a blood transfusion and will receive standard care.
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Participants will receive standard care for ACS while in the hospital.
Outros nomes:
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Comparador Ativo: Standard Care Observational Cohort
Approximately 300 participants who are ineligible for or decline the blood transfusion part of the study will participate in the observational portion of the study and receive standard care.
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Participants will receive standard care for ACS while in the hospital.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Acute Chest Syndrome
Prazo: Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.
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First occurence of positive infiltrate on chest x-ray
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Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sonja McKinlay, PhD, HealthCore-NERI
- Diretor de estudo: Margaret C. Bell, MPH, MS, HealthCore-NERI
Publicações e links úteis
Publicações Gerais
- Miller ST, Kim HY, Weiner D, Wager CG, Gallagher D, Styles L, Dampier CD; Investigators of the Sickle Cell Disease Clinical Research Network (SCDCRN). Inpatient management of sickle cell pain: a 'snapshot' of current practice. Am J Hematol. 2012 Mar;87(3):333-6. doi: 10.1002/ajh.22265. Epub 2012 Jan 9.
- Styles L, Wager CG, Labotka RJ, Smith-Whitley K, Thompson AA, Lane PA, McMahon LE, Miller R, Roseff SD, Iyer RV, Hsu LL, Castro OL, Ataga KI, Onyekwere O, Okam M, Bellevue R, Miller ST; Sickle Cell Disease Clinical Research Network (SCDCRN). Refining the value of secretory phospholipase A2 as a predictor of acute chest syndrome in sickle cell disease: results of a feasibility study (PROACTIVE). Br J Haematol. 2012 Jun;157(5):627-36. doi: 10.1111/j.1365-2141.2012.09105.x. Epub 2012 Mar 30.
- Miller ST, Kim HY, Weiner DL, Wager CG, Gallagher D, Styles LA, Dampier CD, Roseff SD; Investigators of the Sickle Cell Disease Clinical Research Network (SCDCRN). Red blood cell alloimmunization in sickle cell disease: prevalence in 2010. Transfusion. 2013 Apr;53(4):704-9. doi: 10.1111/j.1537-2995.2012.03796.x. Epub 2012 Jul 13.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 668
- U10HL083721 (Concessão/Contrato do NIH dos EUA)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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