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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Children's Healthcare of Atlanta.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Children's Healthcare of Atlanta Identifier:
First received: July 1, 2005
Last updated: March 14, 2012
Last verified: May 2009

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.

Septic Shock
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:

Estimated Enrollment: 80
Study Start Date: May 2005
Estimated Primary Completion Date: December 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.

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

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 identifier: NCT00118664

Contact: Kristine M Rogers, RN 404-785-1215
Contact: James D Fortenberry, MD 404-785-1600

United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Karen B Woronick, RN    202-476-5586   
Principal Investigator: Heidi Dalton, MD         
United States, Georgia
Children's Healthcare of Atlanta at Egleston and Scottish Rite Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kristine M Rogers, RN    404-785-1215   
Contact: James D Fortenberry, MD    404-785-1600   
Principal Investigator: James D Fortenberry, MD         
Sub-Investigator: Munir Kapasi, MD         
United States, Iowa
University of Iowa Children's Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Courtney Harkness    319-356-3988   
Principal Investigator: Patrick Brophy, MD         
United States, Louisiana
LSU Health Sciences Center Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Keith Scott, MD   
Principal Investigator: L. Keith Scott, MD         
United States, Michigan
University of Michigan Medical Center, Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109-0243
Contact: Monica S Weber, RN    734-763-7131   
Principal Investigator: Yong Y Han, MD         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Rod Tarrago, MD    612-863-3226   
Principal Investigator: Rod Tarrago, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Marie Monaco, RN    513-636-5572   
Principal Investigator: Derek S Wheeler, MD         
Columbus Childrens Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark W Hall, MD    614-722-3436   
Principal Investigator: Mark Hall, MD         
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rajesh Aneja, MD    412-692-7366   
Principal Investigator: Rajesh Aneja, MD         
Sub-Investigator: Joseph Carcillo, MD         
United States, Tennessee
Vanderbilt Children's Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: Theresa M. Shalaby, RN, BSN    615-936-1819   
Principal Investigator: Venkat Shankar, MD         
United States, Texas
Cook Children's Hospital Recruiting
Fort Worth, Texas, United States, 76104
Contact: Leigh Donahue, RN, MBA    682-885-6722   
Principal Investigator: James D Marshall, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Will May    832-826-6281      
Principal Investigator: Trung Nguyen, MD         
Sponsors and Collaborators
Children's Healthcare of Atlanta
Principal Investigator: James D. Fortenberry, MD Children's Healthcare of Atlanta
  More Information

Responsible Party: Children's Healthcare of Atlanta Identifier: NCT00118664     History of Changes
Other Study ID Numbers: 05-004 
Study First Received: July 1, 2005
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Multiple Organ Failure
Shock, Septic
Blood Platelet Disorders
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Pathologic Processes
Systemic Inflammatory Response Syndrome processed this record on May 23, 2016