Using a blood recovery system during heart surgery in Brazil
Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial
This study is testing whether using a blood recovery system during heart surgery can help reduce the need for blood transfusions in patients undergoing procedures like bypass surgery or valve surgery in Brazil.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Materno Infantil Prof. Fernando Figueira Academic / other |
| Locations | 1 site (Recife, Pernambuco) |
| Trial ID | NCT06601582 on ClinicalTrials.gov |
What this trial studies
This randomized trial evaluates the effectiveness of an intraoperative blood recovery system in reducing the need for allogeneic blood transfusions during cardiovascular surgeries that utilize cardiopulmonary bypass. Conducted at a teaching hospital in Brazil, patients undergoing coronary artery bypass grafting (CABG) or valve surgery will be randomly assigned to either receive the blood recovery system or not. The study will analyze various data points, including continuous and categorical variables, to determine the system's impact on transfusion rates. Statistical methods will be employed to ensure robust analysis and interpretation of the results.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective CABG or valve surgeries.
Not a fit: Patients undergoing emergency cardiac surgery or those with significant comorbidities such as severe anemia or coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the reliance on donor blood transfusions during heart surgeries, enhancing patient safety and outcomes.
How similar studies have performed: Previous studies have shown promising results with intraoperative blood recovery systems in various surgical settings, indicating potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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);
Where this trial is running
Recife, Pernambuco
- Integral Medicine Institute Professor. Fernando Figueira-IMIP — Recife, Pernambuco, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.