Randomized Anticoagulation Trial in Opcab (RATIO) (RATIO)
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|ClinicalTrials.gov Identifier: NCT02812355|
Recruitment Status : Unknown
Verified May 2017 by Michele Triggiani, Azienda Ospedaliera di Lecco.
Recruitment status was: Recruiting
First Posted : June 24, 2016
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Drug: Heparin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: half heparinization
heparin I.V. 150 U/kg
Active Comparator: full heparinization (300 U/kg)
heparin I.V. 300 U/kg
- Composite vascular [ Time Frame: 30 days post-operatively ]Death from vascular causes, perioperative myocardial infarction, stroke.
- Composite major bleeding [ Time Frame: 48 hours post-operatively ]Redo for excessive bleeding, cardiac tamponade, transfusion ≥3 Units of packed red cells or of platelets.
- Post-operative bleeding [ Time Frame: 48 hours post-operatively ]Total bleeding evaluated the morning after surgery (ml.)
- Transfusion of packed red cells (<3 Units) or of platelets [ Time Frame: 30 days post-operatively ]
- Peak value of cardiac biomarker [ Time Frame: 30 days post-operatively ]
- Transient ischemic cerebral attack [ Time Frame: 30 days post-operatively ]
- Mesenteric ischemia (angiography or CT scan) [ Time Frame: 30 days post-operatively ]
- Pulmonary embolus (angiography or CT scan) [ Time Frame: 30 days post-operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812355
|Contact: Michele NR Triggiani, MD, PhDemail@example.com|
|Contact: Antonello S Martino, MDfirstname.lastname@example.org|
|Jilin Heart Hospital||Recruiting|
|Changchun, Jilin, China|
|Contact: Massimo Lemma, MD email@example.com|
|Principal Investigator: Massimo Lemma, MD|
|Lecco, Italy, 23900|
|Contact: Michele Triggiani, MD, PhD +390341253066 firstname.lastname@example.org|
|Azienda Ospedaliera Universitaria di Sassari||Recruiting|
|Contact: Francesco Massi, MD email@example.com|
|Principal Investigator: Michele Portoghese, MD|
|Sub-Investigator: Francesco Massi, MD|
|Principal Investigator:||Michele NR Triggiani, MD, PhD||ASST Lecco|