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C-Reactive Protein as a Predictor of Stem Cell Transplant Complications

This study has been completed.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00179868
First received: September 10, 2005
Last updated: August 26, 2008
Last verified: August 2008

September 10, 2005
August 26, 2008
January 2003
February 2008   (final data collection date for primary outcome measure)
To determine whether quantitative c-reactive protein measurements can predict major morbidity and mortality in pediatric stem cell transplant patients. [ Time Frame: To day +100 post transplant ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00179868 on ClinicalTrials.gov Archive Site
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C-Reactive Protein as a Predictor of Stem Cell Transplant Complications
C-Reactive Protein As a Predictor of Major Transplant Complications in Pediatric Stem Cell Transplant Patients

The purpose of this study is to determine if C-Reactive Protein levels are predictive for complications post transplant.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Children undergoing a stem cell transplant

  • Cancer
  • Leukemia
  • Stem Cell Transplantation
Behavioral: C-Reactive Protein levels

Each patient enrolled in the study will have a serum quantitative c-reactive protein (crp) level drawn on the day of transplant, day 7 of transplant, and twice weekly after that until recovery of neutrophil count (approximately 20-25 days). Patients will be followed for 100 days post-transplant for the development of the following complications:

  1. Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support.
  2. Acute GVHD > grade II defined according to the Seattle criteria
  3. VOD- defined according to the modified Seattle criteria
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 6 months to 20 years
  • Patient undergoing a stem cell transplant (allogeneic, syngeneic, or autologous) at Childrens' Memorial Hospital
  • IRB approved informed consent (and assent for children age 12-17)
Both
6 Months to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179868
SCT 0403 CRP
No
Morris Kletzel, MD, Children's Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
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Principal Investigator: Morris Kletzel, MD Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP