EUCTR2016-001529-15-IT
Active, not recruiting
Phase 1
Randomized Anticoagulation Trial In Opcab HIGH DOSE VERSUS LOW DOSE HEPARINIZATION IN PATIENTS - Randomized Anticoagulation Trial In Opcab
AZIENDA SOCIO-SANITARIA TERRITORIALE DI LECCO (ASST LECCO)0 sites900 target enrollmentSeptember 7, 2021
ConditionsOff-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 transMedDRA version: 20.0Level: LLTClassification code 10011098Term: Coronary bypassSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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
- Sponsor
- AZIENDA SOCIO-SANITARIA TERRITORIALE DI LECCO (ASST LECCO)
- Enrollment
- 900
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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