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

Sponsored by:	Children's Memorial Hospital
Information provided by:	Children's Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00179868

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 II Phase III

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

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

Further study details as provided by Children's Memorial Hospital:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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:

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:

Sepsis- defined as fever, positive blood culture, need for fluid resuscitation and/or pressor support.
Acute GVHD > grade II defined according to the Seattle criteria
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

Children's Memorial Hospital

Investigators

Principal Investigator:

Morris Kletzel, MD

Children's Memorial Hospital

More Information

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

Keywords provided by Children's Memorial Hospital:

cancer
leukemia
stem cell transplant
complications

Study placed in the following topic categories:

Leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009