Bypass Clear Priming for Ventricular Septal Defect Surgery
This study is looking at whether using non-blood fluids to "prime" (fill) the heart-lung machine during cardiac surgery can reduce inflammation in young children. When children have open-heart surgery for a ventricular septal defect (a hole in the heart), a heart-lung machine is used. Typically, this machine is primed with donated blood products. This study wants to see if using non-blood products instead can lead to less inflammation after surgery. Reducing inflammation could help children recover more quickly. Researchers will measure changes in inflammatory markers like TNF-α and IL8 in the blood up to 24 hours after surgery. This study is for children aged 1 to 18 months, weighing between 5-10kg, who need heart surgery performed by Dr. Bohuta or Dr. Greene.
- Study design
- This is an interventional study with a planned enrollment of 60 participants. It is testing a procedure called "clear priming of the bypass pump."
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure inflammatory markers up to 24 hours after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?
At a glance
Conditions
NCT07393243
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Seattle Children's Hospital
Seattle, Washingtonno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Vishal Nigam, MD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital
Who to contact
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Inclusion
Exclusion
What this trial measures
- Changes in RNA expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPBUp to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in TNF-α fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
- Changes in protein expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPBUp to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed ELISA to assess changes in TNF-α fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
- Changes in RNA expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPBUp to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in IL8 fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
- Changes in protein expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPBUp to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via ELISA to assess changes in IL8 fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.