- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta at Egleston and Scottish Rite
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Children's Hospital
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Louisiana
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Shreveport, Louisiana, United States, 71130
- LSU Health Sciences Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-0243
- University of Michigan Medical Center, Mott Children's Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, United States, 43205
- Columbus Childrens Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Children's Hospital
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Texas
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Fort Worth, Texas, United States, 76104
- Cook Children's Hospital
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.)
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James D. Fortenberry, MD, Children'S Healthcare of Atlanta
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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