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NCT07393243 · ClinicalTrials.gov registry record · NA
Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?
A NA study, sponsored by Seattle Children's Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT07393243: Clinical Trial NA study, sponsored by Seattle Children's Hospital.
NCT07393243 is a NA study that has not yet begun recruiting, run by Seattle Children's Hospital. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07393243, a NA study, has not yet begun recruiting, sponsored by Seattle Children's Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
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
Primary Outcome
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.
Interventions
- PROCEDURE Clear priming of the bypass pump
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-02-25 |
| Est. Completion | 2030-12 |
| Phase | NA |
What is known before NCT07393243 opens enrollment
NCT07393243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Clear priming of the bypass pump is the first listed.
NCT07393243 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07393243 about?
NCT07393243 is a clinical study titled "Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?". 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 ty...
What is the current status of trial NCT07393243?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2026-02-25. Estimated completion is 2030-12.
What interventions are being tested in trial NCT07393243?
The interventions under investigation include: Clear priming of the bypass pump (PROCEDURE).
Who is sponsoring clinical trial NCT07393243?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07393243's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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