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Cardiopulmonary bypass (CPB) is a unique clinical scenario that results in widespread activation of the hemostatic system. Conventional CPB interferes with normal hemostasis by diluting hemostatic cells and proteins, through reinfusion of shed blood, and through activation on the bypass circuit surface of multiple systems including platelets, the kallikrein-kinin system, and fibrinolysis . Besides, deleterious effects of cardiopulmonary bypass (CPB) are partly sequelae of blood-foreign surface reactions. The arterial filter is the part of the CPB circuit where blood cells are exposed to high mechanical stress and where cellular aggregates may fasten in large quantitiesiec.
This is a clinical and observational study. It is being performed in the surgical center and intensive care unit of the Heart Institute (InCor) from Faculty of Medicine, University of São Paulo (FMUSP), on patients undergoing cardiac surgery, who satisfy inclusion and exclusion criteria. In the preanesthetic visit, patient assessment of the criteria described in study methodology is verfied. During the surgery, a blood sample is taken to analyze hemostatic function in the begin of cardiopulmonary bypass, before arterial filter (pre-filter) and in the end of cardiopulmonary bypass, after arterial filter (post-filter). Other routine laboratory exams is being colected until first postoperative day, on the eletronic medical records. At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM. Ten arterial filter samples from pre-determined sites and sizes are sent to the clinical laboratory for evaluation of platelet and leukocyte gene expression in arterial filter. Patients will be followed until hospital discharge or 28 days after surgery, regarding allogeneic transfusion needs, reoperation and thromboembolic events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analysis of arterial filters during CPB | This is a clinical and observational study to investigate of blood cells addesion to surfaces of arterial filters during CPB and the impact in coagulations laboratory exams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analysis of arterial filters after CPB | Procedure | At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Types and characteristics of materials entrapped in the arterial line filter of cardiopulmonary bypass | Analysis of the arterial filter from cardiopulmonay bypass circuit by scanning electron microscopy (SEM) | At the beginning and end of cardiopulmonary bypass |
| Platelet and leukocyte gene expression analysis of arterial line filters of cardiopulmonary bypass | Arterial filter samples from predetermined sites and sizes will be analyzed for evaluation of platelet and leukocyte gene expression in arterial filter. | At the beginning and end of cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between blood adhesion cells in arterial filter and coagulation tests | At the beginning and end of cardiopulmonary bypass | |
| Comparison of standard coagulation test | Analysis of coagulation profile will be assessed fibrinogen dosage (mg/dL), D-dimers (ng/mL), hemoglobin(g/dL), hematocrit (%), platelets count (mm³), prothrombin time (s), activated thromboplastin time (s), international normalized ratio. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Filomena Galas, Phd MD | Contact | +551126615560 | filomenagalas@hotmail.com | |
| Chiara Gatto | Contact | +551126615560 | chiaratessmer@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor - Heart Institute - University of Sao Paulo | Recruiting | São Paulo | 05403000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27159065 | Background | Reynolds PS, Middleton P, McCarthy H, Spiess BD. A Comparison of a New Ultrasound-Based Whole Blood Viscoelastic Test (SEER Sonorheometry) Versus Thromboelastography in Cardiac Surgery. Anesth Analg. 2016 Dec;123(6):1400-1407. doi: 10.1213/ANE.0000000000001362. | |
| 8512409 | Background | Borowiec JW, Bylock A, van der Linden J, Thelin S. Heparin coating reduces blood cell adhesion to arterial filters during coronary bypass: a clinical study. Ann Thorac Surg. 1993 Jun;55(6):1540-5. doi: 10.1016/0003-4975(93)91106-w. |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| At the beginning and end of cardiopulmonary bypass, Immediate postoperative; 24 hours and 48 hours after surgery |
| Comparison of free oscillation rheometry profile | Analysis of HEPSCREEN (Reorox) COT1(s),COT2(s), Slope (Pa/min), GMAX (Pa), EAT (Pa), CLOT SR(%) | At the beginning and end of cardiopulmonary bypass |
| 24951020 | Background | Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18. |