Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118664
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2005-07-01
Brief Title:
Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Patient Plasma Response and Outcome in Septic Shock With Thrombocytopenia Associated Multiple Organ Failure in Children
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAMOF
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
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 childs 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
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 childs 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
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 Childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None