Blood Loss, Surgical, Cardiovascular Surgery
Conditions
Keywords
Cardiovascular Surgery, Operative Blood Salvage
Brief summary
Randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass
Detailed description
To evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass, a randomized clinical trial will be conducted. The study will be conducted at a teaching hospital, which is a reference for major cardiac surgeries and receives patients from the Brazilian Unified Health System (SUS). The patients will be randomly assigned to two groups: with and without the use of the system, and allocation concealment will be performed. Continuous variables will be analyzed through frequency distributions and appropriate descriptive measures (mean or median), while categorical variables will be presented through frequency distributions. For categorical variables, the confidence interval will be calculated, conventionally set at 95%. For continuous variables, the T-test will be used to measure differences, while for categorical variables, the McNemar statistical test will be used. For all analyses, a significance level of 5% will be used, and the data will be analyzed according to the intention-to-treat principle.
Interventions
DEVICEUse of a operative blood salvage system
The surgical team will use a operative blood salvage system
Sponsors
Instituto Materno Infantil Prof. Fernando Figueira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all patients undergoing CABG or Valve surgery singly.
Exclusion criteria
* Emergency cardiac surgery; * Previous heart surgery; * End-stage chronic kidney disease; * Inability to receive a blood transfusion (refusal); * Anemia (hemoglobin less than 10g/dl); * Thrombocytopenia (platelet count less than 100,000/mm3); * Coagulopathy (RNI \> 1.5);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion rate | 2 days | Reduction in the volume of packed red blood cells administered intrao peratively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay | 30 days | Number of Hospital stay in days |
| ICU stay | 30 days | Number of ICU stay in days |
| Hospital mortality | 30 days | Rate of Hospital mortality within 30 days |
| Re-operation for bleeding | 30 days | Rate of Re-operation for bleeding |
| Need for renal replacement therapy | 30 days | Rate of Need for renal replacement therapy |
| Mechanical ventilation | 30 days | Time of mechanical ventilation |
Countries
Brazil
Outcome results
None listed