Bloodless Cardiac Surgery for Congenital Heart Disease

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Weight, Emergency surgery, Shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether children undergoing heart surgery without blood products experience better outcomes than those who do. The researchers aim to determine if avoiding blood transfusions can reduce complications and shorten hospital recovery times. Participants include children weighing between 3.5 kg and 12 kg who require planned or urgent heart surgery with a heart-lung machine (cardiopulmonary bypass). As an unphased trial, this study provides a unique opportunity for participants to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

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 blood conservation techniques are safe for cardiac surgery in children?

Research has shown that blood-saving methods used in heart surgery are safe for patients of all ages, including babies. One study found that these methods greatly reduced the need for blood transfusions during open-heart surgery without causing early problems. Another report demonstrated that these techniques can be safely used for people of different ages and surgery complexities by using less blood in the heart-lung machine, which keeps blood moving during surgery. Additionally, bloodless heart surgery, which avoids blood transfusions, is known to be safe and effective for various patient groups. This evidence suggests that blood-saving methods are well-tolerated and safe, making them a promising option for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative blood conservation techniques in cardiac surgery for congenital heart disease. Traditional surgeries often rely on blood transfusions, but this trial compares two strategies that aim to minimize or eliminate the need for donor blood. The "blood prime" method uses the patient's own blood for the cardiopulmonary bypass, while the "clear prime" method uses a clear solution instead. These approaches could reduce risks associated with transfusions, like infections or immune reactions, making surgeries safer for patients.

What evidence suggests that blood conservation techniques are effective for congenital heart disease?

This trial will compare two approaches for cardiopulmonary bypass in bloodless cardiac surgery for congenital heart disease: a blood prime and a clear prime. Research has shown that blood-saving methods during heart surgery can greatly reduce the need for blood transfusions in babies. Studies have found that these methods can lead to better outcomes, such as fewer postoperative complications. Avoiding blood transfusions might also lower the risk of long-term health issues. In children with congenital heart defects, these techniques have demonstrated possible benefits, including faster recovery times. Overall, blood-saving strategies can make heart surgeries safer for children. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for children weighing between 3.5 and 12 kg who need elective or urgent heart surgery with cardiopulmonary bypass, falling under specific risk categories (STAT 1-4). It's not for those over 12kg or under 3.5kg, in emergency situations, the highest risk surgeries (STAT category 5), without a need for bypass, in shock before surgery, or with blood disorders.

Inclusion Criteria

You have a soft tissue sarcoma with a STS STAT category of 1-4.

I am scheduled for heart surgery that requires a heart-lung machine.

My weight is between 3.5 and 12 kilograms.

Exclusion Criteria

My surgery will not need a heart-lung machine.

I was in shock before my surgery.

My weight is either above 12kg or below 3.5kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo cardiac surgery with cardiopulmonary bypass, with or without blood products

1 day

Postoperative Monitoring

Participants are monitored for complications such as chylothorax, wound infection, and other outcomes

30 days

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood Conservation

Trial Overview

The study tests if using blood products to prime the cardiopulmonary bypass circuit during surgery affects recovery compared to using a clear fluid prime. The goal is to see if avoiding blood can reduce complications and shorten ICU/hospital stays.

How Is the Trial Designed?

Group I: Blood prime for cardiopulmonary bypass Active Control 1 Intervention

Group II: clear prime for cardiopulmonary bypass Active Control 1 Intervention

Blood Conservation is already approved in United States for the following indications:

Approved in United States as Blood Conservation Techniques for:

• Congenital Cardiac Surgery

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Published Research Related to This Trial

Minimally invasive surgical techniques for children with congenital heart disease aim to reduce long-term complications associated with traditional surgeries like thoracotomy and sternotomy.

These techniques have shown promise in treating various congenital heart defects, but further advancements are needed to safely and effectively address more complex conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgeons should provide minimally invasive approaches for the treatment of congenital heart disease. Soukiasian, HJ., Fontana, GP.[2014]

A study of 356 patients undergoing congenital cardiac surgery showed that blood conservation methods significantly reduced the need for homologous blood transfusions across all ages and procedural complexities.

The findings support the feasibility of implementing blood conservation strategies in congenital cardiac surgery, highlighting their potential to minimize the risks and costs associated with blood transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood conservation pediatric cardiac surgery in all ages and complexity levels. Karimi, M., Sullivan, JM., Linthicum, C., et al.[2020]

Minimally invasive techniques in congenital cardiac surgery have been limited due to the complexity of heart defects and the need for access to intracardiac structures, but advancements in cannula design are improving this situation.

Image-guided surgery offers a promising approach by using noninvasive imaging to perform reconstructive heart surgery on a beating heart in children, potentially reducing the need for more invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal incision congenital cardiac surgery. del Nido, PJ.[2021]

Restrictive blood transfusion practices during cardiac surgery are associated with better outcomes, and while transfusion-free surgery is challenging for neonates, significant advancements have been made to reduce the need for homologous blood products in older infants and children.

Key techniques such as minimizing prime volume, using microplegia, and salvaging blood can effectively decrease transfusion requirements, making them safe and cost-effective options for all pediatric patients, including emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perfusionist strategies for blood conservation in pediatric cardiac surgery. Durandy, Y.[2021]

Bloodless surgery programs are being developed to respect patients' preferences against blood transfusions, often due to personal beliefs, and involve preoperative identification of these preferences during screening.

A retrospective review of congenital cardiac procedures showed that bloodless cardiac surgery is effective, utilizing techniques like erythropoietin and dietary supplements to minimize the need for transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood conservation in a congenital cardiac surgery program. John, T., Rodeman, R., Colvin, R.[2019]

Minimally invasive surgical techniques for congenital heart disease have been developed and refined over the last decade, leading to improved surgical outcomes and reduced patient trauma.

These advancements aim to enhance both functional recovery and cosmetic results for patients, reflecting a significant shift in surgical practices for congenital heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive surgical options in pediatric heart surgery. Vida, VL., Padalino, MA., Motta, R., et al.[2014]

Minimally invasive techniques for congenital heart repairs are evolving, with many extracardiac repairs now successfully performed thoracoscopically, leading to reduced surgical trauma.

New strategies, such as sternal-sparing incisions and hybrid procedures combining transcatheter and minimally invasive techniques, are enhancing surgical options while maintaining neuroprotection and myocardial protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the trauma of congenital heart surgery. Burke, RP.[2014]

Blood transfusions after cardiac surgery are frequently performed but can pose significant risks, including both infectious and noninfectious complications, and are often not needed.

The article highlights the advantages of bloodless cardiac surgery, emphasizing strategies to conserve blood and reduce or eliminate the need for transfusions, which can enhance patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bloodless cardiac surgery: not just possible, but preferable. Putney, LJ.[2020]

A successful case of bloodless open heart surgery was performed on a 2.89 kg neonate, demonstrating that cardiac surgery can be safely conducted without transfusions when parents refuse them.

To manage the risks of inadequate oxygen delivery and coagulopathy, the medical team employed blood conservation strategies, including erythropoietin and iron supplementation preoperatively, and techniques to minimize blood loss during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusion-free anesthetic management for open heart surgery in a neonate -A case report-. Lee, JM., Byon, HJ., Kim, JT., et al.[2021]

Hybrid surgical and transcatheter interventions for congenital heart disease (CHD) have evolved significantly over the past 30 years, providing substantial hemodynamic benefits in a minimally invasive way.

These techniques can potentially avoid complications associated with traditional surgeries, such as cardiopulmonary bypass, and improve immediate outcomes, especially in infants with conditions like hypoplastic left heart syndrome and ventricular septal defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of hybrid interventions for congenital heart disease. Agrawal, H., Alkashkari, W., Kenny, D.[2018]

Blood conservation strategies in pediatric cardiac surgery are effective and safe, helping to reduce reliance on allogeneic blood transfusions by maximizing the use of patients' own red blood cells.

Implementing a standardized guideline for blood conservation practices can enhance quality outcomes in pediatric cardiac surgery, making these strategies valuable even in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Surgeon's Perspective on Blood Conservation Practice in Pediatric Cardiac Surgery. Karimi, M.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S266627362400281X

Blood conservation in infants undergoing open heart surgery

Blood conservation is associated with significant reduction in usage of blood products during open heart surgery in infants with no significant effect on early ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8844256/

Cardiac Surgery and Blood-Saving Techniques: An Update

Avoiding blood transfusions may help to lower the risk of postoperative complications and long-term mortality. Clinical outcome studies are ...

3.

withpower.com

withpower.com/trial/phase-heart-diseases-4-2023-3566e

Bloodless Cardiac Surgery for Congenital Heart Disease

These techniques have been successfully used to treat various congenital heart defects, suggesting potential benefits for blood conservation and bloodless ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5070332/

Strategies for blood conservation in pediatric cardiac surgery

Blood conservation is possible in children undergoing cardiac surgery with better outcomes. Various modalities available should be used in conjunction with one ...

5.

annalsthoracicsurgery.org

annalsthoracicsurgery.org/article/S0003-4975(10)00956-2/fulltext

The Impact of Blood Conservation on Outcomes in Cardiac ...

Intraoperative red blood cell transfusion during coronary artery bypass graft surgery increases the risk of postoperative low-output heart failure.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5411967/

Blood conservation pediatric cardiac surgery in all ages ...

We demonstrated that the blood conservation practice can be performed safely in all ages and complexity levels by reducing cardiopulmonary bypass prime volume ...

7.

seattlechildrens.org

seattlechildrens.org/healthcare-professionals/provider-news/largest-blood-conservation-program/

Home of the Nation's Largest Blood Conservation Program

Seattle Children's has established itself as a leader in pediatric cardiac care, pioneering one of the most advanced Blood Conservation Programs in the country.