Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children



Status:Completed
Conditions:Hospital, Hematology
Therapuetic Areas:Hematology, Other
Healthy:No
Age Range:Any - 18
Updated:6/15/2016
Start Date:May 2005
End Date:February 2012

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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.

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 thrombocytopenia-associated multiple organ failure (TAMOF), has been demonstrated to
predispose affected children to worsening organ failure and increased risk of death. A
preliminary single-center study performed at Children's Hospital of Pittsburgh (CHP)
suggested significant improvement in organ system dysfunction in TAMOF patients using a
plasma exchange protocol compared to standard therapy alone. The investigators desire to
further evaluate plasma profiles and clinical outcomes in pediatric TAMOF in a broader
geographic setting. The investigators propose to perform a prospective multi-center
observational cohort study to evaluate plasma response and clinical outcomes in pediatric
patients with TAMOF due to critical illness associated with systemic infection, sepsis,
organ transplant, chemotherapy or cardiopulmonary bypass. Plasma samples will be obtained
from all patients for measurement of markers of coagulation and inflammation. The primary
clinical endpoints measured will be organ failure index scores, pediatric logistic organ
dysfunction (PELOD) scores, and days until resolution of organ failures. Cohort outcome
analysis will also be performed by pairing patients at different centers receiving standard
therapy with those receiving plasma exchange as an additional therapy.

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.)
We found this trial at
12
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Ann Arbor, MI
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Atlanta, GA
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Columbus, Ohio 43205
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Columbus, OH
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Fort Worth, Texas 76104
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Fort Worth, TX
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Iowa City, IA
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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Nashville, TN
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Shreveport, Louisiana
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Shreveport, LA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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