Blood Cell Adhesion to Arterial Filters During Cardiac Surgery

NCT03882593 | Unknown

• 1 other identifier: 4279.15.106
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Coagulation Disorders; C.Surgical Procedure; Cardiac

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Correlation between blood adhesion cells in arterial filter and coagulation tests

  At the beginning and end of cardiopulmonary bypass

• Comparison of standard coagulation test

  At the beginning and end of cardiopulmonary bypass, Immediate postoperative; 24 hours and 48 hours after surgery

• Comparison of free oscillation rheometry profile

  At the beginning and end of cardiopulmonary bypass

Study Arms (1)

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

Procedure: Analysis of arterial filters after CPB

Interventions

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At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.

Analysis of arterial filters during CPB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 27159065 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.

  PMID: 8512409 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.

  PMID: 24951020 BACKGROUND

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Filomena Galas, Phd MD

CONTACT

+551126615560; filomenagalas@hotmail.com

Chiara Gatto

CONTACT

+551126615560; chiaratessmer@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology at University São Paulo Medical School

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: March 20, 2019
• Study Start: August 30, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

BR (1)