← Back to Search

N/A

Bloodless Cardiac Surgery for Congenital Heart Disease

N/A
Recruiting
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elective and urgent cardiac surgery with cardiopulmonary bypass
Patient weight 3.5-12kg
Must not have
Patients whose surgery does not require cardiopulmonary bypass
Patients presenting preoperatively in shock
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial evaluates if bloodless cardiac surgery has benefits for patients 3.5-12kg, such as reduced morbidity/mortality & shorter hospital stays.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial compares the use of blood versus clear fluids during surgery rather than medication side effects per se, potential risks may include typical surgical and postoperative complications such as infection or delayed recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for heart surgery that requires a heart-lung machine.
Select...
My weight is between 3.5 and 12 kilograms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My surgery will not need a heart-lung machine.
Select...
I was in shock before my surgery.
Select...
My weight is either above 12kg or below 3.5kg.
Select...
I am having emergency surgery.
Select...
I have a known blood disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Blood prime for cardiopulmonary bypassActive Control1 Intervention
Group II: clear prime for cardiopulmonary bypassActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,540 Total Patients Enrolled

Media Library

Blood Conservation (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05881564 — N/A
Congenital Heart Disease Research Study Groups: Blood prime for cardiopulmonary bypass, clear prime for cardiopulmonary bypass
Congenital Heart Disease Clinical Trial 2023: Blood Conservation Highlights & Side Effects. Trial Name: NCT05881564 — N/A
Blood Conservation (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05881564 — N/A
~31 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top