NCT06601582

Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil

Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Surgery
• Blood Loss, Surgical

Interventions

Type	Name	Description
DEVICE	Use of a operative blood salvage system	The surgical team will use a operative blood salvage system

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Brazil