- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00118664
Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children (TAMOF)
The purpose of this study is to learn how blood clotting substances respond in children with septic shock, low platelet counts, and multiple organ failure (MOF) treated at different institutions.
Multiple organ failure can be related to an infection producing "septic shock," in which substances released in the blood cause poor blood flow to the organs. The number of platelets circulating in your child's blood stream is also decreased (this is called "thrombocytopenia") as a result of this condition. Research has shown that certain substances in the part of the blood known as plasma (the clear liquid part of the blood not including the red blood cells but holding blood clotting factors) can cause the organs to work poorly. The investigators would like to compare these blood responses in children with this condition, receiving a variety of different treatments, for multiple organ failure in other medical centers around the world. The investigators hope to enroll 80 patients into the study.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Children's National Medical Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Children's Healthcare of Atlanta at Egleston and Scottish Rite
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Children's Hospital
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71130
- LSU Health Sciences Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0243
- University of Michigan Medical Center, Mott Children's Hospital
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics of Minnesota
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- CIncinnati Children's Hospital Medical Center
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Columbus, Ohio, Forenede Stater, 43205
- Columbus Childrens Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt Children's Hospital
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Hospital
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
All pediatric Intensive Care Unit (ICU) patients with the following inclusion criteria are eligible for enrollment:
- Weight > 5 kilograms (minimum weight required due to technical limits of exchange equipment)
- Multiple organ failure, defined as organ failure index (OFI) score > 3 present for < 30 hours
- Patients must have new (not present prior to admission) organ failure in at least 3 of the 5 organ systems.
- Thrombocytopenia (platelet count < 100,000 per ul), or in patients with a baseline platelet count < 100,000 per ul, a minimum 50% decrease in platelet count
- Etiology of MOF due to systemic infection, shock, transplantation, chemotherapy, or cardiopulmonary bypass
Exclusion Criteria:
- Treatment prior to study entry with any form of plasma exchange therapy within 30 days not for TAMOF
- Thrombocytopenia secondary to diagnosed thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS)
- Patients with terminal illness (i.e. not expected to live > 60 days even if they survive this acute illness) or in which withdrawal of therapy is being considered (do-not-resuscitate [DNR]/comfort measures only, limited therapy etc.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: James D. Fortenberry, MD, Children's Healthcare of Atlanta
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 05-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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