[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"apheresis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:apheresis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":4,"leadSponsor":42,"locationsCount":45},"100054778","collection-and-distribution-of-blood-components-from-healthy-donors-for-in-vitro-research-use-100054778",false,"NCT00001846","Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use","* ELIGIBILITY CRITERIA:\n\nDonors must meet the eligibility criteria for volunteer blood donation, defined in the Code of Federal Regulations 21 CFR 640, and AABB Standards as modified in the 2007 FDA\u002FCBER Guidance Document: Eligibility Criteria for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, with the exception of foreign travel history and other conditions, as noted below:\n\n* Ability of subject to understand, ask questions, and the willingness to provide written informed consent\n* Age greater than or equal to 18 years\n* Weight greater than 110 pounds\n* Female subjects should not be pregnant\n* No known heart, lung, kidney disease, or bleeding disorders\n* No history of sickle cell disease\n* No history of engaging in high-risk activities for exposure to the AIDS virus, as defined in the AABB Donor Education Materials distributed to all donors. Deferral periods for high-risk activities (MSM, IV drug use or receipt of money or drugs in exchange for sex) will not exceed the corresponding deferral period as defined for allogeneic blood donors.\n* No history of malaria in the past 12 months\n* Donors who have a family history of CJD, donors who have undergone tattooing or body piercing, donors who have received a graft such as bone, skin or dura mater, donors who are taking finasteride or retinoids, and donors who have had sexual contact within the past 12 months with a person who has symptomatic hepatitis C infection or donors who have lived with a person who has hepatitis in the last 12 months, are similarly eligible for research-use only donations on this protocol.\n* Donors who have traveled to Europe, Africa, Asia, and areas of South America, who are rendered ineligible for allogeneic donation due to malarial risk, Zika risk and vCJD risk, are eligible for research donations\n* Donors with a history of repeat false positive HTLV I\u002FII, who are rendered ineligible for allogeneic donation, are eligible for research donations.\n* Donors with a positive antibody to hepatitis B core antigen (anti-HBc) only, without other positive infectious disease markers,are eligible for research donations.\n* Donors with HLA antibodies are eligible for research donations\n* Donors who have received an experimental drug, agent, or vaccine, and who are referred for a research blood, plasma or leukocyte collection, specifically because they were given this drug, agent, or vaccine, are acceptable only if their research product is collected for use by the PI who administered the experimental drug, agent, or vaccine. Otherwise, they are deferred for one year after receiving an experimental drug, agent, or vaccine.\n* Donors who have received a xenotransplant are eligible for research donations.\n* Granulocyte donors may not receive dexamethasone if they have poorly controlled hypertension or diabetes, or if they have a history of cataracts. Hetastarch (also known as hydroxyethyl starch or \"HES\") and dexamethasone may elevate blood pressure and raise blood glucose levels, and repetitive steroid administration may increase the risk of posterior subcapsular cataract formation or progression.\n* Granulocyte donors must have an estimated glomerular filtration (eGFR) rate of \\> 45ml\u002Fmin\u002F1.73m\\^2.\n* Granulocyte donors may not receive filgrastim if they have a history or symptoms of coronary heart disease.\n\nInvestigators are informed that eligibility standards for research donors differ from those for transfusion donors through an electronic \"User Agreement\" which they electronically sign when they register to receive blood components on this protocol.",true,"ALL","18 Years","100 Years",{"count":20,"type":21},5000,"ESTIMATED","OBSERVATIONAL","This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors.\n\nBlood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards...",[25,26,27],"Blood Donors","Research Subjects","Apheresis",[29,30,31,32,33,34],"Volunteer Donor","Research Samples","Leukapheresis","Plateletpheresis","Plasmapheresis","Natural History","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2001-01-11",{"name":43,"class":44},"National Institutes of Health Clinical Center (CC)","NIH",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100434641","crp-apheresis-in-stemi-100434641","NCT04939805","CRP Apheresis in STEMI","Selective C-reactive Protein Apheresis in ST-elevation Myocardial Infarction","Inclusion Criteria:\n\n1. Diagnosis of first acute STEMI in accordance with the European Society of Cardiology (ESC) Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation\n2. Symptoms consistent with STEMI with beginning greater than 30 minutes but less than 12 hours prior to primary percutaneous coronary intervention (PCI)\n3. CRP elevation of ≥7 mg\u002Fl measured between 6 to 16 hours after primary PCI\n4. Eligible for primary PCI\n5. Age ≥18 years\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Prior acute myocardial infarction, coronary artery bypass surgery or PCI.\n2. Persistent hemodynamic instability (Killip class \\>2 including cardiogenic shock) or resuscitated cardiac arrest not allowing a CMR scan.\n3. The patient is febrile (temperature \\>38°C) or has experienced an acute infection with fever in the last 14 days.\n4. CRP \\>15 mg\u002Fl at time of hospital admission.\n5. Chronic inflammatory disease.\n6. Known history of severe hepatic failure\n7. Chronic kidney disease with a creatinine clearance \\\u003C30ml\u002Fmin.\u002F1.73m²\n8. Contraindication to CMR.\n9. Pre-STEMI life expectancy of \\\u003C1 year\n10. Participation in another interventional trial\n11. Limited possibility to join the follow-up examinations (e.g. patient lives abroad)\n12. Pregnancy","85 Years",{"count":55,"type":21},202,"INTERVENTIONAL",[58],"NA","Background: In patients with acute ST-elevation myocardial infarction (STEMI), the amount of infarcted myocardium (infarct size) is known to be a major predictor for adverse remodeling and recurrent adverse cardiovascular events. Effective cardio-protective strategies with the aim of reducing infarct size are therefore of great interest. Local and systemic inflammation influences the fate of ischemic myocardium and thus, adverse remodeling and clinical outcome. C-reactive protein (CRP) also acts as a potential mechanistic mediator that adversely affects the amount of irreversible myocardial tissue damage after acute myocardial infarction.\n\nObjective: The main objectives of the current study are to investigate the efficacy of selective CRP apheresis, using the PentraSorb®-CRP system, as an adjunctive therapy to standard of care for patients with acute STEMI treated with primary PCI.\n\nDesign: Investigator-initiated, prospective, randomized, open-label (outcome assessors masked), controlled, multicenter, two group trial with a two-stage adaptive design.\n\nInnovation: Selective CRP apheresis offers potential to decrease infarct size and consequently improve outcome after PCI for STEMI. This is the first randomized trial investigating the impact of selective CRP apheresis on infarct size in post-STEMI patients. In perspective, the study design allows furthermore to collect robust evidence for the design of a definitive outcome study.",[61,62,27,63],"ST Elevation Myocardial Infarction","C-Reactive Protein","Myocardial Injury",[65],"Cardiac magnetic resonance imaging","2025-05-06",{"date":68,"type":39},"2025-05-09",{"date":70,"type":39},"2021-04-01",{"date":72,"type":21},"2025-08-31",{"name":74,"class":75},"Medical University Innsbruck","OTHER",5]