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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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

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My weight is between 3.5 and 12 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

2Treatment groups

Active Control

Group I: Blood prime for cardiopulmonary bypassActive Control1 Intervention

Group II: clear prime for cardiopulmonary bypassActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor

211 Previous Clinical Trials

84,918 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of this investigation’s participant pool?

"Indeed, clinicaltrials.gov attests to the active recruitment of 150 patients from one trial site since its posting on May 10th 2023 and subsequent editing on May 19th."

Answered by AI

Is this clinical trial enrolling participants presently?

"Affirmative. Records on clinicaltrials.gov attest to this medical trial's current recruitment efforts, which began on May 10th 2023 and were last amended on May 19th of the same year. The study is searching for 150 patients from a single centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery

2023. "Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05881564.