Blood Coagulation Disorders Clinical Trial
Official title:
Blood Cell Adhesion to Arterial Filters During Cardic Surgery - Observational Clinical Study: Scanning Electron Microscopy and Cell Gene Expression Analysis
NCT number | NCT03882593 |
Other study ID # | 4279.15.106 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 30, 2018 |
Est. completion date | December 2019 |
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Cardiac surgeries with extracorporeal circulation in patients older than 18 years - Written and signed informed consent - Preanesthetic assessment and preoperatory exams in accordance with study methodology Exclusion Criteria: - Active infection; - Previously coagulopathy; - Antiplatelet therapy use until 10 days before surgery (except acetylsalicylic acid and enoxaparin that may be used in prophylactic doses until 24h before surgery); |
Country | Name | City | State |
---|---|---|---|
Brazil | Incor - Heart Institute - University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto do Coracao |
Brazil,
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. — View Citation
Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Câmara L, Guimarães 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | Correlation between blood adhesion cells in arterial filter and coagulation tests | At the beginning and end of cardiopulmonary bypass | ||
Secondary | 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. | At the beginning and end of cardiopulmonary bypass, Immediate postoperative; 24 hours and 48 hours after surgery | |
Secondary | 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 |
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