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

• Sponsor: Augusta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05881564
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Other: blood use for priming cardiopulmonary bypass circuit; Other: clear prime for cardiopulmonary bypass	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
• Actual Study Start Date: May 10, 2023
• Anticipated Primary Completion Date: May 11, 2025
• Anticipated Study Completion Date: May 12, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Blood prime for cardiopulmonary bypass	Other: blood use for priming cardiopulmonary bypass circuit; one arm will have the cardiopulmonary bypass circuit primed with blood
Active Comparator: clear prime for cardiopulmonary bypass	Other: clear prime for cardiopulmonary bypass; this arm will not have bypass circuit primed with blood

Outcome Measures

Primary Outcome Measures

1. Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   age in months

2. Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   weight in kg

3. Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   sex

4. Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   race

5. Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   preoperative diagnosis

6. Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   surgery performed

7. Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   any previous surgery

8. Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   blood product received

9. Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

   volume of blood transfusion in mL

10. Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    unplanned reoperation

11. Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    unplanned cardiac catheterization

12. Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    neurologic complication

13. Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    chylothorax

14. Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    vocal cord injury

15. Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    diaphragm paralysis

16. Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    pacemaker implantation

17. Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    postoperative pneumothorax

18. Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    wound infection

19. Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    bleeding requiring reoperation

20. Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    pericardial effusion

21. Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable) [30 days]

    mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient weight 3.5-12kg

• Elective and urgent cardiac surgery with cardiopulmonary bypass

• Cases within the STS STAT categories of 1-4

Exclusion Criteria:

• Patients who weigh more than 12kg or less than 3.5kg.

• Patients undergoing emergency surgery.

• STAT category 5 cases.

• Patients whose surgery does not require cardiopulmonary bypass.

• Patients presenting preoperatively in shock.

• Patients with known blood dyscrasias.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Georgia	Augusta	Georgia	United States	30912

Sponsors and Collaborators

• Augusta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Augusta University
• ClinicalTrials.gov Identifier: NCT05881564
• Other Study ID Numbers: 2000190-3
• First Posted: May 31, 2023
• Last Update Posted: Jun 1, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital

Study Results

No Results Posted as of Jun 1, 2023