Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06601582

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integral Medicine Institute Professor. Fernando Figueira-IMIP

Recife, Pernambuco, 50070550, Brazil

Location status: Recruiting

Location contact

Cristiano BC Cunha, PhD

CONTACT

Igor Silva, MD

CONTACT

Igor T Silva, MD

CONTACT

[email protected]

55 81 999829569

Livia B Andrade, phD student

CONTACT

[email protected]

55 81 91548350

Livia Ba Andrade, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Use of a operative blood salvage system

Device

The surgical team will use a operative blood salvage system

Primary outcomes

  1. Blood transfusion rate

    Time frame: 2 days

    Reduction in the volume of packed red blood cells administered intrao peratively

Secondary outcomes

  1. Hospital mortality

    Time frame: 30 days

    Rate of Hospital mortality within 30 days

  2. Hospital Stay

    Time frame: 30 days

    Number of Hospital stay in days

  3. ICU stay

    Time frame: 30 days

    Number of ICU stay in days

  4. Mechanical ventilation

    Time frame: 30 days

    Time of mechanical ventilation

  5. Re-operation for bleeding

    Time frame: 30 days

    Rate of Re-operation for bleeding

  6. Need for renal replacement therapy

    Time frame: 30 days

    Rate of Need for renal replacement therapy

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil. Randomized Crontrolled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.