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

Instituto Materno Infantil Prof. Fernando Figueira

Status: Enrolling

Conditions: Blood Loss, Surgical; Cardiovascular Surgery

Treatments: Device: Use of a operative blood salvage system

Study type: Interventional

Funder types: Other

Identifiers

NCT06601582

IMIFernandoFigueira

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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);

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention

Experimental group

Description:

Device: Use of a operative blood salvage system The surgical team will use a operative blood salvage system

Treatment:

Device: Use of a operative blood salvage system

No intervention

No Intervention group