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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00118664
First received: July 1, 2005
Last updated: June 13, 2016
Last verified: June 2016
  Purpose

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.


Condition
Septic Shock
Thrombocytopenia
Multiple Organ Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 86
Study Start Date: May 2005
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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 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.
  Eligibility

Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients admitted to a participating PICU.
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118664

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Children's Healthcare of Atlanta at Egleston and Scottish Rite
Atlanta, Georgia, United States, 30322
United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
United States, Louisiana
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71130
United States, Michigan
University of Michigan Medical Center, Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-0243
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Columbus Childrens Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
United States, Texas
Cook Children's Hospital
Fort Worth, Texas, United States, 76104
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: James D. Fortenberry, MD Children's Healthcare of Atlanta
  More Information

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00118664     History of Changes
Other Study ID Numbers: 05-004 
Study First Received: July 1, 2005
Last Updated: June 13, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Children's Healthcare of Atlanta:
Septic Shock
Thrombocytopenia
Multiple Organ Failure
Pediatric

Additional relevant MeSH terms:
Shock
Shock, Septic
Thrombocytopenia
Multiple Organ Failure
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 26, 2016