on prevista

Phase 1

• Conditions: Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG),OPCAB, like any other surgical procedure, determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in CABG, and that lasts as long as one month. Therefore systemic heparinization is necessary in OPCAB to prevent thrombotic complications during trans; MedDRA version: 20.0Level: LLTClassification code 10011098Term: Coronary bypassSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-001529-15-IT
• Lead Sponsor: AZIENDA SOCIO-SANITARIA TERRITORIALE DI LECCO (ASST LECCO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

All consecutive patients undergoing elective multivessel OPCAB, aged >18 years, of both sexes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

Exclusion criteria are represented by the diagnosis of acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparinization or sub-cutaneous low molecular weight heparin (LMWH), known coagulopathy, documented liver disease, chronic renal failure (creatinine = 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the hypothesis that in OPCAB low dose heparinization is superior to high dose heparinization for the prevention of major perioperative bleeding events, without an higher rate of thrombotic complications.;Secondary Objective: To reduce the need for red blood cell and platelets transfusions;Primary end point(s): Composite vascular endpoint (death from vascular causes, perioperative myocardial infarction, stroke), and composite peri-operative major bleeding endpoint (redo for excessive bleeding, cardiac tamponade, transfusion =3 Units of packed red cells or of platelets).;Timepoint(s) of evaluation of this end point: 30 days post-operatives

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Post-operative bleeding, transfusion of <3 Units of packed red cells or of platelets, peak value of cardiac biomarker, transient ischemic cerebral attack, bowel ischemia, pulmonary embolus.;Timepoint(s) of evaluation of this end point: 30 days