Clinical trial NCT03882593: Blood Cell Adhesion to Arterial Filters During Cardiac Surgery
Official title: Blood Cell Adhesion to Arterial Filters During Cardic Surgery - Observational Clinical Study: Scanning Electron Microscopy and Cell Gene Expression Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Coagulation Disorders
C.Surgical Procedure; Cardiac
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2019-03-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)

Brief summary: 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.

Detailed description: 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 At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.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.

Eligibility criteria: 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);

Primary outcomes:
measure: Types and characteristics of materials entrapped in the arterial line filter of cardiopulmonary bypass
timeFrame: At the beginning and end of cardiopulmonary bypass
measure: Platelet and leukocyte gene expression analysis of arterial line filters of cardiopulmonary bypass
timeFrame: At the beginning and end of cardiopulmonary bypass
Secondary outcomes:
measure: Correlation between blood adhesion cells in arterial filter and coagulation tests
timeFrame: At the beginning and end of cardiopulmonary bypass
measure: Comparison of standard coagulation test
timeFrame: At the beginning and end of cardiopulmonary bypass, Immediate postoperative; 24 hours and 48 hours after surgery
measure: Comparison of free oscillation rheometry profile
timeFrame: At the beginning and end of cardiopulmonary bypass
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
References:
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. doi: 10.1213/ANE.0000000000001362.
citation: 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.
citation: 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.