Differences in Outcomes for Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery Who Receive Blood Versus Those Who do Not
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient weight 3.5-12kg
- •Elective and urgent cardiac surgery with cardiopulmonary bypass
- •Cases within the STS STAT categories of 1-4
排除标准
- •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.
结局指标
主要结局
Previous surgery prior to bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
any previous surgery
Volume transfused during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
volume of blood transfusion in mL
Number of patients with diaphragm paralysis in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
diaphragm paralysis
Surgery performed in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
surgery performed
Number of patients with vocal cord injury in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
vocal cord injury
Weight of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
weight in kg
Number of patients with a neurologic complication in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
neurologic complication
Number of patients with chylothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
chylothorax
Number of patients with wound infection in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
wound infection
Number of patients with bleeding requiring reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
bleeding requiring reoperation
Age of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
age in months
Number of patients with unplanned reoperation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
unplanned reoperation
Number of patients with unplanned cardiac catheterization in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
unplanned cardiac catheterization
Number of patients with pericardial effusion in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
pericardial effusion
Number of patients who died following bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
mortality
Gender of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
sex
Demographics of bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
race
Diagnosis of patients undergoing bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
preoperative diagnosis
Blood received during bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
blood product received
Number of patients with pacemaker implantation in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
pacemaker implantation
Number of patients with postoperative pneumothorax in bloodless cardiac surgery in patients 3.5-12kg (categorical variable)
时间窗: 30 days
postoperative pneumothorax
次要结局
未报告次要终点