Blood Cell Adhesion to Arterial Filters During Cardiac Surgery

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882593
• Other study ID #: 4279.15.106
• Status: Recruiting
• Start date: August 30, 2018
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Instituto do Coracao
• Contact: Filomena Galas, Phd MD
• Phone: +551126615560
• Email: filomenagalas[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.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

Recruitment information / eligibility

• 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);

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• C.Surgical Procedure; Cardiac
• Hemostatic Disorders

Intervention

Procedure:
• Analysis of arterial filters after CPB
At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.

Locations

Country	Name	City	State
Brazil	Incor - Heart Institute - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

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