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

Cancer Clinical Trial

Official title:

C-Reactive Protein As a Predictor of Major Transplant Complications in Pediatric Stem Cell Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179868
• Other study ID #: SCT 0403 CRP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2005
• Last updated: August 26, 2008
• Start date: January 2003
• Est. completion date: February 2008

Study information

• Verified date: August 2008
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 20 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Leukemia
• Stem Cell Transplantation

Intervention

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: 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

Locations

Country	Name	City	State
United States	Children's Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether quantitative c-reactive protein measurements can predict major morbidity and mortality in pediatric stem cell transplant patients.		To day +100 post transplant	No