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
  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:


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
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 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 October 19, 2014