Clinical trial NCT05881564: Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery
Official title: Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
measure: Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Children's Hospital of Georgia
state: Georgia
Study officials:
References: