|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Rochester |
|---|---|
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00693498 |
Purpose
Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself. In general, the more intense their inflammatory response, the more critically ill they are following surgery. These children routinely require large numbers of blood transfusions during and following surgery as part of their medical management that adds to their heightened inflammatory state. Whether additional steps to "wash" blood products and remove the substances contributing to post-transfusion inflammation will limit this response, and improve the health of children following open heart surgery, remains to be studied.
Aims: To compare the inflammatory response in children having open heart surgery who receive washed versus unwashed blood transfusions.
Methods: We will randomly assign children having open heart surgery to one of two groups: group 1 will receive blood transfusions per the current standard of care, group 2 will receive blood transfusions that have been washed in addition to the current standard of care. We will then use blood tests to measure the inflammatory response in children of each group. We will compare the results to determine whether washing blood transfusions decreases inflammation and post-operative complications following open heart surgery.
Conclusion: We believe that washing blood transfusions given to children following open heart surgery will decrease their inflammatory response and improve their overall health.
| Condition | Intervention |
|---|---|
|
Congenital Heart Disease |
Biological: Standard leukoreduced irradiated blood cell transfusion Biological: Washed leukoreduced irradiated blood cell transfusions |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Standard vs. Washed Blood Cell Transfusions in Pediatric Cardiac Surgery: Impact on Post-Operative Inflammation as Evidenced by the IL-6 to IL-10 Ratio. |
| Estimated Enrollment: | 128 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Standard leukoreduced irradiated blood cell transfusion group
|
Biological: Standard leukoreduced irradiated blood cell transfusion
standard vs washed blood cell transfusions
|
|
2: Experimental
Washed leukoreduced irradiated blood cell transfusion group
|
Biological: Washed leukoreduced irradiated blood cell transfusions
washed leukoreduced irradiated blood cell transfusions
|
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jill Cholette, MD | 585-275-0189 | Jill_Cholette@urmc.rochester.edu |
| Contact: Jill Cholette, MD | 585-275-0189 |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jill Cholette, MD 585-275-0189 Jill_Cholette@urmc.rochester.edu | |
| Principal Investigator: Jill M Cholette, MD | |
| Principal Investigator: | Jill Cholette, MD | University of Rochester |
More Information
| Responsible Party: | University of Rochester ( Jill M. Cholette, MD ) |
| Study ID Numbers: | 24518 |
| Study First Received: | June 5, 2008 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00693498 |
| Health Authority: | United States: Institutional Review Board |
|
pediatrics congenital heart disease |
|
Heart Diseases Cardiovascular Abnormalities Congenital Abnormalities Heart Defects, Congenital Inflammation |
|
Cardiovascular Diseases |
