- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00951808
Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)
Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
Oakland, California, Förenta staterna
- Children's Hospital and Research Center
-
-
Delaware
-
Wilmington, Delaware, Förenta staterna
- A.I. Dupont Hospital for Children
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna
- Children's National Medical Center
-
Washington, District of Columbia, Förenta staterna
- Howard University Hospital
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna
- Emory University School of Medicine
-
Augusta, Georgia, Förenta staterna
- Medical College of Georgia
-
-
Illinois
-
Chicago, Illinois, Förenta staterna
- Children's Memorial Hospital
-
Chicago, Illinois, Förenta staterna
- University of Illinois Sickle Cell Center
-
-
Kentucky
-
Louisville, Kentucky, Förenta staterna
- Kosair Children's Hospital
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna
- Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna
- Children's Hospital Boston
-
Boston,, Massachusetts, Förenta staterna
- Boston Medical Center
-
Boston,, Massachusetts, Förenta staterna
- Brigham & Women's Hospital
-
-
Mississippi
-
Jackson, Mississippi, Förenta staterna
- University of Mississippi Medical Center
-
-
New York
-
Brooklyn, New York, Förenta staterna
- Interfaith Medical Center
-
Brooklyn, New York, Förenta staterna
- New York Methodist Hospital
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna
- The University of North Carolina at Chapel Hill
-
Durham, North Carolina, Förenta staterna
- Duke University Medical Center
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna
- Cincinnati Children's Hospital Medical Center
-
Columbus, Ohio, Förenta staterna
- Ohio State University
-
Columbus, Ohio, Förenta staterna
- Nationwide Children's Hospital
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Förenta staterna
- St. Christopher's Hospital for Children
-
-
Virginia
-
Richmond, Virginia, Förenta staterna
- Virginia Commonwealth University Health Systems
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
Andra namn:
|
Aktiv komparator: 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.
Andra namn:
|
Aktiv komparator: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Acute Chest Syndrome
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Sonja McKinlay, PhD, HealthCore-NERI
- Studierektor: Margaret C. Bell, MPH, MS, HealthCore-NERI
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 668
- U10HL083721 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Sicklecellanemi
-
Second Affiliated Hospital of Guangzhou Medical...Hunan Zhaotai Yongren Medical Innovation Co. Ltd.RekryteringAnti-cancercellsimmunterapi | T Cell och NK CellKina
-
City of Hope Medical CenterNational Cancer Institute (NCI)AvslutadAnaplastiskt storcelligt lymfom | Återkommande mogna T-cell och NK-cell non-Hodgkin lymfom | Refraktärt mogen T-cell och NK-cell non-Hodgkin lymfomFörenta staterna
-
Ohio State University Comprehensive Cancer CenterMerck Sharp & Dohme LLCRekryteringSezary syndrom | Kronisk lymfatisk leukemi | Perifert T-cellslymfom | Primärt kutant T-cell non-Hodgkin lymfom | T-cell prolymfocytisk leukemi | B-cell prolymfocytisk leukemiFörenta staterna
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeRefraktärt mogen T-cell och NK-cell non-Hodgkin lymfom | Mogen T-cell och NK-cell non-Hodgkin lymfom | Återkommande moget T- och NK-cells non-Hodgkin-lymfom | Återkommande kutant T-cell non-Hodgkin lymfom | Refraktärt kutant T-cell non-Hodgkin lymfomFörenta staterna
-
Johnson & Johnson Pharmaceutical Research & Development...AvslutadPure Red-cell AplasiaStorbritannien, Sverige, Sydafrika, Brasilien, Kanada, Tyskland, Norge, Thailand
-
Emory UniversityRekryteringFollikulärt lymfom | Diffust stort B-cellslymfom | Mantelcellslymfom | Kronisk lymfatisk leukemi | Mogen T-cell och NK-cell non-Hodgkin lymfomFörenta staterna
-
Fundación Academia Española de DermatologíaRekryteringLymfom, B-cell | Lymfom, stor B-cell, diffus | Lymfom, B-cell, marginalzon | Lymfom, T-cell, kutan | Sezary syndrom | Lymfom, extranodal NK-T-cellSpanien
-
Assistance Publique - Hôpitaux de ParisHar inte rekryterat ännu
-
Bing HanAvslutadPure Red Cell Aplasia, förvärvadKina
-
First Affiliated Hospital Xi'an Jiaotong UniversityEureka Therapeutics Inc.OkändCD19+ lymfom, B-cell | CD19+ leukemi, B-cellKina
Kliniska prövningar på Single blood transfusion
-
Helios Klinik Gotha/OhrdrufHelios Klinikum ErfurtHar inte rekryterat ännu
-
Daping Hospital and the Research Institute of Surgery...Children's Hospital of Chongqing Medical UniversityIndragenAnemi | Nekrotiserande enterokolit | Transfusion av röda blodkroppar (RBC).Kina
-
Assistance Publique - Hôpitaux de ParisAvslutadHjärtinfarkt | Anemi | BlodtransfusionSpanien, Frankrike
-
Second Affiliated Hospital, School of Medicine,...AvslutadSpinal Fusion | Lungkomplikation | TransfusionKina
-
Christiana Care Health ServicesUniversity of Pennsylvania; Temple University Hospital; Pennsylvania HospitalAvslutadBlodtransfusion | För tidig | Hypoxi NeonatalFörenta staterna
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)AvslutadJärn, onormal blodnivå | Annan onormal blodkemiFörenta staterna
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Rekrytering
-
Centre Leon BerardAvslutadBlödning | Transfusion | CancerkirurgiFrankrike
-
University Hospital, LilleAvslutadPostoperativa komplikationer | Erytrocyttransfusion | SyresjukdomarFrankrike
-
Direction Centrale du Service de Santé des ArméesUniversity Hospital, GrenobleAvslutad