An observational study in Blood Coagulation Disorders and C.Surgical Procedure; Cardiac, sponsored by Instituto do Coracao. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Instituto do Coracao · Observational
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 At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.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.
147 studies on the registry are indexed under Blood Coagulation Disorders; 15 are open to participants now.
This study's planned enrollment of 28 is below the median of 120 across 58 observational studies indexed under Blood Coagulation Disorders.
Browse Blood Coagulation Disorders studies →Instituto do Coracao is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.
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)
Time frame: 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.
Time frame: At the beginning and end of cardiopulmonary bypass
Correlation between blood adhesion cells in arterial filter and coagulation tests
Time frame: 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.
Time frame: 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(%)
Time frame: At the beginning and end of cardiopulmonary bypass
Started Aug 2018 (actual). Primary completion is estimated for May 2019, 9 months after the start.
Of 29 observational studies under Blood Coagulation Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 59. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Instituto do Coracao