Randomized Anticoagulation Trial in Opcab (RATIO)

Ischemic Heart Disease Clinical Trial

— RATIO  

Official title:

High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812355
• Other study ID #: EudraCT n. 2016-001529-15
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2016
• Last updated: May 11, 2017
• Start date: January 2017
• Est. completion date: February 2019

Study information

• Verified date: May 2017
• Source: Azienda Ospedaliera di Lecco
• Contact: Michele NR Triggiani, MD, PhD
• Phone: +39-0341253066
• Email: m.triggiani[@]asst-lecco.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG). OPCAB 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 in OPCAB systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. An internationally accepted standard intra-operative anticoagulation protocol for OPCAB has not yet been defined, and heparinization in OPCAB is a highly variable practice. The intraoperative anticoagulation regimen adopted in patients undergoing OPCAB may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (RCT). The 2 most widespread intraoperative anticoagulation protocols in OPCAB are represented by full (300 U/kg) or half (150 U/kg) heparinization, with target ACT ranging from 200 sec to >480 sec.

Patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. Randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: February 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Heparin

Locations

Country	Name	City	State
China	Jilin Heart Hospital	Changchun	Jilin
Italy	ASST Lecco	Lecco
Italy	Azienda Ospedaliera Universitaria di Sassari	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Lecco

Countries where clinical trial is conducted

China,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite vascular	Death from vascular causes, perioperative myocardial infarction, stroke.	30 days post-operatively
Primary	Composite major bleeding	Redo for excessive bleeding, cardiac tamponade, transfusion =3 Units of packed red cells or of platelets.	48 hours post-operatively
Secondary	Post-operative bleeding	Total bleeding evaluated the morning after surgery (ml.)	48 hours post-operatively
Secondary	Transfusion of packed red cells (<3 Units) or of platelets		30 days post-operatively
Secondary	Peak value of cardiac biomarker		30 days post-operatively
Secondary	Transient ischemic cerebral attack		30 days post-operatively
Secondary	Mesenteric ischemia (angiography or CT scan)		30 days post-operatively
Secondary	Pulmonary embolus (angiography or CT scan)		30 days post-operatively

External Links

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