Status:
COMPLETED
Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
Lead Sponsor:
Children's Healthcare of Atlanta
Conditions:
Septic Shock
Thrombocytopenia
Eligibility:
All Genders
6-18 years
Brief Summary
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. Mul...
Detailed Description
Researchers have defined a subgroup of pediatric patients with critical illness who have a specific coagulation profile associated with thrombocytopenia. This distinct entity, defined as thrombocytope...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00118664
Start Date
May 1 2005
End Date
February 1 2012
Last Update
June 14 2016
Active Locations (12)
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1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
Children's Healthcare of Atlanta at Egleston and Scottish Rite
Atlanta, Georgia, United States, 30322
3
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
4
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71130