Clear Priming for Ventricular Septal Defects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using non-blood fluids instead of donated blood to fill the heart-lung machine during surgery (clear priming of the bypass pump) can reduce inflammation after heart surgery. It targets babies between 1 and 18 months old who need surgery to repair a ventricular septal defect. The goal is to determine if less inflammation leads to a quicker and easier recovery. Participants will provide blood samples to help researchers understand inflammation and its potential triggers. Families with infants needing this type of surgery might consider participating. As an unphased trial, this study offers families the chance to contribute to groundbreaking research that could improve surgical outcomes for infants.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this method is safe for pediatric cardiac surgery?
Research has shown that using fluids other than blood to prepare the bypass pump during heart surgery might be safe. Although specific data proving the safety of this method is not yet available, it is currently being tested in a trial. Experts continue to study it to ensure its safety.
The goal of using non-blood fluids is to reduce inflammation, which can occur when blood products are used. Inflammation can slow recovery after surgery. By reducing inflammation, this method might also lower other side effects of bypass surgery.
The main aim is to determine if this approach works well and is manageable for patients. If it proves safe and effective, it could lead to a quicker and smoother recovery for young patients undergoing heart surgery.12345Why are researchers excited about this trial?
Researchers are excited about clear priming for ventricular septal defects because it uses a unique approach by priming the bypass pump with non-blood fluids, unlike the standard method that combines crystalloid solution with blood. This new method could potentially reduce the risk of blood-related complications during cardiac surgery. By avoiding blood products, clear priming may also lower the chances of immune reactions and transmission of infections, which are important considerations for patient safety.
What evidence suggests that clear priming of the bypass pump is effective for reducing inflammation in pediatric heart surgery?
Research has shown that using fluids other than blood in the heart-lung machine during children's heart surgery might help reduce swelling. Swelling can occur after surgery and may slow recovery. Some studies have found that these non-blood fluids lead to less swelling compared to blood. In this trial, participants in the "Clear prime" arm will have the bypass pump primed with a mixture of crystalloid solution and non-blood fluids. In past cases, children who underwent surgery with non-blood fluids did not experience any major negative effects, and this method was considered safe. This approach aims to help children recover faster after surgery to repair holes in the heart.12346
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
Citations
Study Details | NCT07393243 | Bypass Clear Priming VSD ...
Hematocrit was consistently lower post-operatively for patients in the crystalloid only group, otherwise, there were no unintended consequences/ ...
Clear Priming for Ventricular Septal Defects
... Clear priming of the bypass pump will have tolerable side effects & efficacy for patients with Pneumonia, Ventricular Septal Defects and ...
3.
ctv.veeva.com
ctv.veeva.com/study/bypass-clear-priming-vsd-cardiopulmonary-bypass-circuit-reduce-bypass-associated-inflammationBypass Clear Priming VSD Cardiopulmonary Bypass Circuit ...
With this project, the investigator are studying if filling the bypass pump with non-blood products reduces the bypass-associated inflammation.
Fresh Frozen Plasma in Pump Priming for Congenital Heart ...
The inclusion of FFP in pump priming for congenital heart surgery in infants and children was shown to improve the hemodilution-related hemostatic dysfunction.
Outcomes of perventricular off-pump versus conventional ...
CONCLUSIONS: According to the mid-term follow-up results, PVDC has similar efficacy to CA for VSD closure. The off-pump PVDC technique reduces blood product ...
Post-myocardial infarction ventricular septal defects - PMC - NIH
Six patients survived to discharge and were followed up for 30 days. Primary outcomes included the incidence of post-MI VSD across the years ...
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