Clear Priming for Ventricular Septal Defects
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery. The study will focused on pediatric participants who require open heart surgery to repair certain types holes in the heart.
Typically for pediatric patients, the cardiopulmonary bypass pump is "primed" (filled) with donated blood products. This project is going to test if the exposure to these blood products causes inflammation. Patients experience significant inflammation (swelling) after undergoing cardiopulmonary bypass. This inflammation can interfere and slow down the patient's recovery from cardiac surgery. With this project, the investigator are studying if filling the bypass pump with non-blood products reduces the bypass-associated inflammation.
The investigators are also studying if using non-blood fluids to fill the bypass pump reduces bypass associated side effects.
The investigators are also trying to understand how the inflammation starts. The investigators also want to study genetic material called DNA that is collected from a person's blood. Instructions for the body are contained in parts of DNA called genes. Genes determine things like hair and eye color. The investigator hope by studying genes the investigator can learn more about the inflammation that occurs after heart surgery, but the investigators might use participant's genetic information to study other diseases or conditions other the inflammation that occurs after heart surgery.
The investigators will be studying the recovery of 60 participants between 1 month to 18 months of age who require open heart surgery to repair ventricular septal defects (VSDs), a congenital heart defect where there a hole between the lower chambers of the heart.
Participants will:
Allow for information about how the participants recover from surgery to be collected.
Allow blood samples during and after surgery to be collected to understand how the markers of inflammation change between the two groups (blood versus non-blood priming).
Who Is on the Research Team?
Vishal Nigam, MD
Principal Investigator
Seattle Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pediatric patients aged 1-18 months, weighing between 5-10kg, who need open heart surgery to fix holes in the heart (VSDs). The surgery must be part of their clinical care and performed by Dr. Bohuta or Dr. Greene.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Immediate Post-operative Monitoring
Participants undergo cardiac surgery with either blood or non-blood priming of the bypass pump. Blood samples are collected during and after surgery to assess inflammation markers.
Follow-up
Participants are monitored for safety and effectiveness after surgery, including length of hospital stay and time to extubation.
What Are the Treatments Tested in This Trial?
Interventions
- Clear priming of the bypass pump
Trial Overview
The study tests if using non-blood fluids instead of donated blood to prime the cardiopulmonary bypass pump reduces inflammation after heart surgery in children with VSDs. It also examines changes in DNA that may explain this inflammation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The research participants in this arm will undergo their clinically indicated cardiac surgery. The experimental group will have the bypass pump primed with mixture of crystalloid solution, non-blood fluids.
The research participants in this arm will undergo their clinically indicated cardiac surgery. The control group will have the bypass pumped primed with mixture of crystalloid solution and blood, which is currently standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
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