Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?

NCT07393243 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00003941
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 to be collected to understand how the markers of inflammation change between the two groups (blood versus non-blood priming).

Conditions

Ventricular Septal Defect

Keywords

cardiac surgery; cardiopulmonary bypass; inflammation; blood product

Outcome Measures

Primary Outcomes (4)

• Changes in RNA expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB

  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.

  Up to 24 hours post surgery

• Changes in protein expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB

  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.

  Up to 24 hours post surgery

• Changes in RNA expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB

  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.

  Up to 24 hours post surgery

• Changes in protein expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB

  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.

  Up to 24 hours post surgery

Secondary Outcomes (4)

• Time to extubation

  From intubation until extubation (up to 24 hours post-surgery)

• Peak lactic acid levels over the first 24 hours post-surgery

  Up to 24 hours post-surgery

• Vasoactive-inotropic score over the first 24 hours post-surgery

  Up to 24 hours post-surgery

• Length of hospital stay post-surgery

  From the date of surgery until the date of hospital discharge, assessed up to 90 days post-surgery.

Study Arms (2)

Blood prime

NO INTERVENTION

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.

Clear prime

EXPERIMENTAL

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.

Procedure: Clear priming of the bypass pump

Interventions

Clear priming of the bypass pump PROCEDURE

The intervention is priming the pump with non-blood products.

Clear prime

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Weight between 5-10kg
• Age 1-18 months
• Requiring cardiopulmonary bypass as part of clinically indicated surgery
• Surgery performed by Dr. Bohuta or Dr. Greene

You may not qualify if:

• Hemoglobin/hematocrit too low for clear CPB prime (post-dilution Hct \<24%)
• Pre-operative ECMO support
• Active infection
• Not clinically appropriate for clear prime (instability, arrhythmias, desaturation, etc.)
• Genetic syndrome
• Pork allergy or family requests pork avoidance

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98115, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Inflammation

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vishal Nigam, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie A Lammers, BSN

CONTACT

2069875916; stephanie.lammers@seattlechildrens.org

Kira A Spencer, PhD

CONTACT

206-987-2000; kira.spencer@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: February 6, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of publication, deidentified IPD will be shared.

Locations

US (1)