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

Trial Summary

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 data supports the effectiveness of the treatment Blood Conservation, Bloodless Cardiac Surgery, Blood Conservation Techniques for congenital heart disease?

Research shows that minimally invasive techniques, which are part of bloodless cardiac surgery, can reduce surgical trauma and improve recovery times for patients with congenital heart disease. These techniques have been successfully used to treat various congenital heart defects, suggesting potential benefits for blood conservation and bloodless surgery approaches. ^{1 2 3 4 5}

Is bloodless cardiac surgery safe for humans?

Bloodless cardiac surgery, which uses techniques to minimize or avoid blood transfusions, is considered safe and effective for patients of all ages and complexity levels. These methods reduce the risks associated with blood transfusions and have been successfully implemented in clinical practice. ^{6 7 8 9 10}

How is the treatment Blood Conservation different from other treatments for congenital heart disease?

Blood Conservation, or bloodless cardiac surgery, is unique because it minimizes or eliminates the need for blood transfusions during surgery by using techniques like reducing the priming volume of the bypass circuit, using blood salvage systems, and administering medications like erythropoietin to boost red blood cell production. This approach is particularly beneficial for patients who cannot receive blood transfusions due to personal or religious reasons. ^{6 8 9 10 11}

What is the purpose of this trial?

To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Surgeons should provide minimally invasive approaches for the treatment of congenital heart disease. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Minimally invasive surgical options in pediatric heart surgery. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Minimal incision congenital cardiac surgery. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evolution of hybrid interventions for congenital heart disease. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Reducing the trauma of congenital heart surgery. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Blood conservation in a congenital cardiac surgery program. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Blood conservation pediatric cardiac surgery in all ages and complexity levels. [2020]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Transfusion-free anesthetic management for open heart surgery in a neonate -A case report-. [2021]