- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00951808
Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)
Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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California
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Oakland, California, Spojené státy
- Children's Hospital and Research Center
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Delaware
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Wilmington, Delaware, Spojené státy
- A.I. Dupont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Spojené státy
- Children's National Medical Center
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Washington, District of Columbia, Spojené státy
- Howard University Hospital
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Georgia
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Atlanta, Georgia, Spojené státy
- Emory University School of Medicine
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Augusta, Georgia, Spojené státy
- Medical College of Georgia
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Illinois
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Chicago, Illinois, Spojené státy
- Children's Memorial Hospital
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Chicago, Illinois, Spojené státy
- University of Illinois Sickle Cell Center
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Kentucky
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Louisville, Kentucky, Spojené státy
- Kosair Children's Hospital
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Maryland
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Baltimore, Maryland, Spojené státy
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Spojené státy
- Children's Hospital Boston
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Boston,, Massachusetts, Spojené státy
- Boston Medical Center
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Boston,, Massachusetts, Spojené státy
- Brigham & Women's Hospital
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Mississippi
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Jackson, Mississippi, Spojené státy
- University of Mississippi Medical Center
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New York
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Brooklyn, New York, Spojené státy
- Interfaith Medical Center
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Brooklyn, New York, Spojené státy
- New York Methodist Hospital
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North Carolina
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Chapel Hill, North Carolina, Spojené státy
- The University of North Carolina at Chapel Hill
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Durham, North Carolina, Spojené státy
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Spojené státy
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, Spojené státy
- Ohio State University
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Columbus, Ohio, Spojené státy
- Nationwide Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Spojené státy
- St. Christopher's Hospital for Children
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Virginia
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Richmond, Virginia, Spojené státy
- Virginia Commonwealth University Health Systems
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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.
Ostatní jména:
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Aktivní komparátor: 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.
Ostatní jména:
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Aktivní komparátor: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Acute Chest Syndrome
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Sonja McKinlay, PhD, HealthCore-NERI
- Ředitel studie: Margaret C. Bell, MPH, MS, HealthCore-NERI
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 668
- U10HL083721 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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