Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of a operative blood salvage system.
- Who it may be relevant to
- Registry conditions: Cardiovascular Surgery, Blood Loss, Surgical. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial
Overview
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
- Device Use of a operative blood salvage system
The surgical team will use a operative blood salvage system
Primary outcome measures
- Blood transfusion rate [Time frame: 2 days]
Secondary outcome measures (6)
- Hospital mortality [Time frame: 30 days]
- Hospital Stay [Time frame: 30 days]
- ICU stay [Time frame: 30 days]
- Mechanical ventilation [Time frame: 30 days]
- Re-operation for bleeding [Time frame: 30 days]
- Need for renal replacement therapy [Time frame: 30 days]
Eligibility criteria
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);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- Integral Medicine Institute Professor. Fernando Figueira-IMIP — Recife
Identifiers
NCT: NCT06601582 · IMIFernandoFigueira