Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Materno Infantil Prof. Fernando Figueira
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
all patients undergoing CABG or Valve surgery singly.
Disqualifiers
Emergency cardiac surgery;
Previous heart surgery;
End-stage chronic kidney disease;
Inability to receive a blood transfusion (refusal);
Trial design
Design model
Parallel
Treatments tested in this trial
Use of a operative blood salvage system
DeviceThe surgical team will use a operative blood salvage system
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Blood transfusion rate
Reduction in the volume of packed red blood cells administered intrao peratively
Time frame
2 daysSecondary outcomes
1
Hospital mortality
Rate of Hospital mortality within 30 days
Time frame
30 days2
Hospital Stay
Number of Hospital stay in days
Time frame
30 days3
ICU stay
Number of ICU stay in days
Time frame
30 days4
Mechanical ventilation
Time of mechanical ventilation
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov