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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Device: Use of a operative blood salvage system The surgical team will use a operative blood salvage system |
|
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of a operative blood salvage system | Device | The surgical team will use a operative blood salvage system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood transfusion rate | Reduction in the volume of packed red blood cells administered intrao peratively | 2 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
18 years old and older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integral Medicine Institute Professor. Fernando Figueira-IMIP | Recruiting | Recife | Pernambuco | 50070550 | Brazil |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| 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 |