- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00951808
Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)
Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Oakland, California, États-Unis
- Children's Hospital and Research Center
-
-
Delaware
-
Wilmington, Delaware, États-Unis
- A.I. Dupont Hospital for Children
-
-
District of Columbia
-
Washington, District of Columbia, États-Unis
- Children's National Medical Center
-
Washington, District of Columbia, États-Unis
- Howard University Hospital
-
-
Georgia
-
Atlanta, Georgia, États-Unis
- Emory University School of Medicine
-
Augusta, Georgia, États-Unis
- Medical College of Georgia
-
-
Illinois
-
Chicago, Illinois, États-Unis
- Children's Memorial Hospital
-
Chicago, Illinois, États-Unis
- University of Illinois Sickle Cell Center
-
-
Kentucky
-
Louisville, Kentucky, États-Unis
- Kosair Children's Hospital
-
-
Maryland
-
Baltimore, Maryland, États-Unis
- Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis
- Children's Hospital Boston
-
Boston,, Massachusetts, États-Unis
- Boston Medical Center
-
Boston,, Massachusetts, États-Unis
- Brigham & Women's Hospital
-
-
Mississippi
-
Jackson, Mississippi, États-Unis
- University of Mississippi Medical Center
-
-
New York
-
Brooklyn, New York, États-Unis
- Interfaith Medical Center
-
Brooklyn, New York, États-Unis
- New York Methodist Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, États-Unis
- The University of North Carolina at Chapel Hill
-
Durham, North Carolina, États-Unis
- Duke University Medical Center
-
-
Ohio
-
Cincinnati, Ohio, États-Unis
- Cincinnati Children's Hospital Medical Center
-
Columbus, Ohio, États-Unis
- Ohio State University
-
Columbus, Ohio, États-Unis
- Nationwide Children's Hospital
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, États-Unis
- St. Christopher's Hospital for Children
-
-
Virginia
-
Richmond, Virginia, États-Unis
- Virginia Commonwealth University Health Systems
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Blood Transfusion Trial Cohort
Twenty participants will receive a blood transfusion while in the hospital.
|
Participants will receive a single transfusion of 7-13cc/kg packed red blood cells (RBCs) while in the hospital.
Autres noms:
|
Comparateur actif: Standard Care Trial Cohort
Twenty participants will not receive a blood transfusion and will receive standard care.
|
Participants will receive standard care for ACS while in the hospital.
Autres noms:
|
Comparateur actif: 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.
|
Participants will receive standard care for ACS while in the hospital.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Acute Chest Syndrome
Délai: 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.
|
First occurence of positive infiltrate on chest x-ray
|
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.
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sonja McKinlay, PhD, HealthCore-NERI
- Directeur d'études: Margaret C. Bell, MPH, MS, HealthCore-NERI
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 668
- U10HL083721 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Drépanocytose
-
The Lymphoma Academic Research OrganisationNovartis; Gilead SciencesRecrutementÉligible en hématopathologie ou traitement CAR-t CellFrance
-
Stiftung Swiss Tumor InstituteKlinik Hirslanden, Zurich; Palleos Healthcare GmbHRecrutementMesures des résultats rapportés par les patients | Thérapie CAR T-CellSuisse
-
Dartmouth-Hitchcock Medical CenterComplétéLymphome | Leucémie | Myélome multiple | Greffe de cellules souches | Greffe de cellules souches hématopoïétiques | Thérapie CAR T-Cell | GCSH | Thérapie cellulaire | Transplantation CAR T-CellÉtats-Unis
-
Shenzhen Fifth People's HospitalRecrutement
-
Manchester University NHS Foundation TrustUniversity of Manchester; The Christie NHS Foundation Trust; Zenzium AI Ltd.; Aptus... et autres collaborateursRecrutementCancer colorectal | Cancer du poumon | Cancer hématologique | Thérapie CAR T-CellRoyaume-Uni
-
Sun Yat-sen UniversityPas encore de recrutementCancer du col de l'utérus | Effet de la chimiothérapie | Thérapie néoadjuvante | Programmed Cell Death 1 Receptor / Antagonistes et inhibiteurs
-
University of Alabama at BirminghamRésiliéLymphome anaplasique à grandes cellules | Lymphome T angio-immunoblastique | Lymphomes T périphériques | Leucémie à cellules T de l'adulte | Lymphome T adulte | Lymphome T périphérique Non précisé | T/Null Cell Systemic Type | Lymphome cutané à cellules T avec maladie nodale/viscéraleÉtats-Unis
-
Adelphi Values LLCBlueprint Medicines CorporationComplétéLeucémie mastocytaire (MCL) | Mastocytose systémique agressive (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | Mastocytose systémique fumante (SSM) | Mastocytose systémique indolente (ISM) Sous-groupe ISM entièrement recrutéÉtats-Unis
-
The First Affiliated Hospital of Xiamen UniversityRecrutementCarcinome réfractaire de la glande thyroïde | Carcinome papillaire de la glande thyroïde réfractaire | Carcinome folliculaire de la glande thyroïde réfractaire | Carcinome réfractaire de la glande thyroïde Hurthle CellChine
-
National Cancer Institute (NCI)ComplétéCarcinome différencié de la glande thyroïde réfractaire | Carcinome de la glande thyroïde non résécable | Carcinome papillaire de la glande thyroïde réfractaire | Carcinome folliculaire de la glande thyroïde réfractaire | Carcinome réfractaire de la glande thyroïde Hurthle CellÉtats-Unis, Canada
Essais cliniques sur Single blood transfusion
-
National Institutes of Health Clinical Center (CC)RecrutementThrombocytopénie | Réfractaire des transfusions plaquettaires (PTR)États-Unis
-
Assistance Publique - Hôpitaux de ParisComplétéInfarctus du myocarde | Anémie | Transfusion sanguineEspagne, France
-
Hamad Medical CorporationSidra Medical and Research Center; World Anti-Doping Agency; Anti-Doping Lab... et autres collaborateursInconnueMaladie du sang | Transfusion sanguine, autologue | Dopage sanguin | Transfusion sanguine, homologueQatar
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Etablissement... et autres collaborateursRecrutementL'accent est mis sur la détection des conséquences de la transfusion sanguine autologue chez des volontaires sainsFrance
-
Hospital PitangueirasInconnueMaladies cardiaquesBrésil
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)RésiliéLeucémie myéloïde aiguë | Myélofibrose primaire | Thrombocytopénie | Leucémie aiguë lymphoblastique | La leucémie lymphocytaire chronique | Thromboembolie veineuse | Syndrome myélodysplasique | Lymphome non hodgkinien à cellules B | Receveur de greffe de cellules hématopoïétiques | Leucémie myéloïde... et d'autres conditionsÉtats-Unis
-
Haukeland University HospitalDentsply Sirona Implants and ConsumablesComplété
-
Emory UniversityRetiréTumeur des cellules hématopoïétiques et lymphoïdes | Leucémie | Anémie | Syndrome myélodysplasique | Anémie aplastique | Insuffisance de la moelle osseuseÉtats-Unis
-
Daping Hospital and the Research Institute of Surgery...Children's Hospital of Chongqing Medical UniversityRetiréAnémie | Entérocolite nécrosante | Transfusion de globules rouges (GR)Chine
-
University of OklahomaComplétéThrombocytopénieÉtats-Unis