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

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

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical; Cardiovascular Surgery
• Intervention / Treatment: Device: Use of a operative blood salvage system

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070550
      • Recruiting
      • Integral Medicine Institute Professor. Fernando Figueira-IMIP
      • Contact: Livia B Andrade, phD student; Phone Number: 55 81 91548350; Email: ftliviabandrade@gmail.com
      • Contact: Igor T Silva, MD; Phone Number: 55 81 999829569; Email: igortc.silva@gmail.com
      • Contact: Livia Ba Andrade, PhD
      • Contact: Cristiano BC Cunha, PhD
      • Contact: Igor Silva, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Experimental: Intervention; Device: Use of a operative blood salvage system The surgical team will use a operative blood salvage system	Device: Use of a operative blood salvage system; The surgical team will use a operative blood salvage system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood transfusion rate	Reduction in the volume of packed red blood cells administered intrao peratively	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital mortality	Rate of Hospital mortality within 30 days	30 days
Hospital Stay	Number of Hospital stay in days	30 days
ICU stay	Number of ICU stay in days	30 days
Mechanical ventilation	Time of mechanical ventilation	30 days
Re-operation for bleeding	Rate of Re-operation for bleeding	30 days
Need for renal replacement therapy	Rate of Need for renal replacement therapy	30 days

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: September 15, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular Surgery; Operative Blood Salvage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: IMIFernandoFigueira

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No