Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601582
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-04-28
Brief Title:
Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery Using Cardiopulmonary Bypass in Brazil Randomized Crontrolled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None