NCT00179868

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

September 10, 2005

Last Update Submit

February 4, 2025

Conditions

CancerLeukemiaStem Cell Transplantation

Keywords

cancerleukemiastem cell transplantcomplications

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

C-Reactive Protein levelsBEHAVIORAL

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 Criteria

Age6 Months - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing a stem cell transplant

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

NeoplasmsLeukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Morris Kletzel, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 16, 2005

Study Start

January 1, 2003

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

US(1)