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

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

August 26, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00179868 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Children undergoing a stem cell transplant

Condition ^ICMJE

Cancer
Leukemia
Stem Cell Transplantation

Intervention ^ICMJE

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

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

6 Months to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00179868

Other Study ID Numbers ^ICMJE

SCT 0403 CRP

Has Data Monitoring Committee

Responsible Party

Morris Kletzel, MD, Children's Memorial Hospital

Study Sponsor ^ICMJE

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Morris Kletzel, MD

Ann & Robert H Lurie Children's Hospital of Chicago

Information Provided By

Ann & Robert H Lurie Children's Hospital of Chicago

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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