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

NCT ID: NCT00179868

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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Conditions

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Cancer Leukemia Stem Cell Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morris Kletzel, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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SCT 0403 CRP

Identifier Type: -

Identifier Source: org_study_id

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