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Clinical Trials/EUCTR2016-001529-15-IT
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

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.

Registry
who.int
Start Date
September 7, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA SOCIO-SANITARIA TERRITORIALE DI LECCO (ASST LECCO)

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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