Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

Congenital Heart Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693498
• Other study ID #: 24518
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: January 4, 2018
• Start date: July 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

1. age < 18 years

2. surgical repair at URMC by the pediatric cardiac surgical team

3. informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject.

Exclusion Criteria:

1. Age =18 years

2. inability to provide consent/assent; 3) subjects having "emergent" surgical procedures. Subjects with chronic inflammatory or autoimmune disorders will not be excluded

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Biological:
• Standard leukoreduced irradiated blood cell transfusion
standard vs washed blood cell transfusions
• Washed leukoreduced irradiated blood cell transfusions
washed leukoreduced irradiated blood cell transfusions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio	plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.	12 hours post-cardiopulmonary bypass
Secondary	Median wrCRP Level	wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects	post op day 1 and 2