Overview

Randomized Anticoagulation Trial in Opcab (RATIO)

Status:
Unknown status
Trial end date:
2019-02-01
Target enrollment:
0
Participant gender:
All
Summary
The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Ospedaliera di Lecco
Treatments:
Calcium heparin
Heparin
Criteria
Inclusion Criteria:

Consecutive patients electively undergoing multivessel OPCAB

Exclusion Criteria:

Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet
drug should be suspended 5 days before surgery), on-going intravenous heparin or
sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease,
chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery,
previous cardiac surgery.