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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00179868
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 27, 2008
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago

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

Condition or disease Intervention/treatment
Cancer Leukemia Stem Cell Transplantation Behavioral: C-Reactive Protein levels

Study Type : Observational
Estimated Enrollment : 44 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   6 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing a stem cell transplant

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00179868

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

Responsible Party: Morris Kletzel, MD, Children's Memorial Hospital Identifier: NCT00179868     History of Changes
Other Study ID Numbers: SCT 0403 CRP
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 27, 2008
Last Verified: August 2008

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