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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
History of Changes
  Purpose

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


Condition Intervention Phase
Cancer
Leukemia
Stem Cell Transplantation
 Behavioral: C-Reactive Protein levels
 Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: C-Reactive Protein As a Predictor of Major Transplant Complications in Pediatric Stem Cell Transplant Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia
U.S. FDA Resources

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: January 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children undergoing a stem cell transplant

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179868

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Morris Kletzel, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Morris Kletzel, MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00179868     History of Changes
Other Study ID Numbers: SCT 0403 CRP
Study First Received: September 10, 2005
Last Updated: August 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
cancer
leukemia
stem cell transplant
complications

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013