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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cardiovascular Surgery Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Device: Use of a operative blood salvage system The surgical team will use a operative blood salvage system

Group Type EXPERIMENTAL

Use of a operative blood salvage system

Intervention Type DEVICE

The surgical team will use a operative blood salvage system

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Use of a operative blood salvage system

The surgical team will use a operative blood salvage system

Intervention Type DEVICE

Eligibility Criteria

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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);

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes