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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
Sponsor:
Information provided by (Responsible Party):
Michele Triggiani, Azienda Ospedaliera di Lecco

Brief 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).

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Drug: Heparin Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: half heparinization
heparin I.V. 150 U/kg
Drug: Heparin
Active Comparator: full heparinization (300 U/kg)
heparin I.V. 300 U/kg
Drug: Heparin



Primary Outcome Measures :
  1. Composite vascular [ Time Frame: 30 days post-operatively ]
    Death from vascular causes, perioperative myocardial infarction, stroke.

  2. 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.


Secondary Outcome Measures :
  1. Post-operative bleeding [ Time Frame: 48 hours post-operatively ]
    Total bleeding evaluated the morning after surgery (ml.)

  2. Transfusion of packed red cells (<3 Units) or of platelets [ Time Frame: 30 days post-operatively ]
  3. Peak value of cardiac biomarker [ Time Frame: 30 days post-operatively ]
  4. Transient ischemic cerebral attack [ Time Frame: 30 days post-operatively ]
  5. Mesenteric ischemia (angiography or CT scan) [ Time Frame: 30 days post-operatively ]
  6. Pulmonary embolus (angiography or CT scan) [ Time Frame: 30 days post-operatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Michele NR Triggiani, MD, PhD +39-0341253066 m.triggiani@asst-lecco.it
Contact: Antonello S Martino, MD +39-0341253651 as.martino@asst-lecco.it

Locations
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China, Jilin
Jilin Heart Hospital Recruiting
Changchun, Jilin, China
Contact: Massimo Lemma, MD       dr.lemma@jlheart.org   
Principal Investigator: Massimo Lemma, MD         
Italy
ASST Lecco Recruiting
Lecco, Italy, 23900
Contact: Michele Triggiani, MD, PhD    +390341253066    m.triggiani@asst-lecco.it   
Azienda Ospedaliera Universitaria di Sassari Recruiting
Sassari, Italy
Contact: Francesco Massi, MD       fmassi@aslsassari.it   
Principal Investigator: Michele Portoghese, MD         
Sub-Investigator: Francesco Massi, MD         
Sponsors and Collaborators
Azienda Ospedaliera di Lecco
Investigators
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Principal Investigator: Michele NR Triggiani, MD, PhD ASST Lecco

Additional Information:
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Responsible Party: Michele Triggiani, MD, PhD, Azienda Ospedaliera di Lecco
ClinicalTrials.gov Identifier: NCT02812355     History of Changes
Other Study ID Numbers: EudraCT n. 2016-001529-15
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michele Triggiani, Azienda Ospedaliera di Lecco:
off-pump
coronary artery bypass
heparinization
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action