Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

Study Overview
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Brief Summary
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Because the impairment of platelet function may cause excess peri-operative bleeding, pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. We aimed to evaluate the impact of a low-molecular-weight-heparin (LMWH), enoxaparin, and unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in patients undergoing elective coronary artery bypass grafting (CABG) surgery after aspirin discontinuation. The specific hypothesis of this study was that a 12 h interval is sufficient not to cause excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic efficacy and haemorrhagic safety.

Detailed Description
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Since LMWH provide many pharmacokinetic advantages compared with UFH, and since they are a valid substitution for UFH in a number of settings, such as non-ST elevation acute coronary syndromes and prevention of venous thromboembolism, LMWH may provide a useful bridge to revascularization after aspirin discontinuation in patients undergoing CABG surgery. Obstacles to the spreading of this practice are mainly the absence of solid evidence of equivalence (or superiority) as to efficacy in this setting, and the proof of equal safety, namely the absence of excess bleeding because some studies have suggested an increased number of haemorrhagic complications after LMWH, particularly with the use of higher doses. This might here be a problem, as patients are here generally at high risk of thrombotic events and for this reason need higher doses than for prevention of venous thromboembolism.

Official Title
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Effect of Low Molecular Weight Heparin vs Unfractionated Heparin on Bleeding After Cardiac Surgery

Conditions
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Coronary Disease, Coronary Artery Bypass Grafting

Intervention / Treatment
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* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 35-75 years with 3-vessel coronary artery disease (CAD) Candidates to elective CABG Exclusion Criteria: Other additional (valve, carotid, etc.) simultaneous surgery required, Off-pump surgery, Any altered liver and kidney laboratory parameters, A history of any haemorrhagic disorders, Platelet count <100,000 and >450.000/μL, Treatment with ticlopidine or clopidogrel in the last month.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enoxaparin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin Concentration |  |  | 
| Haematocrit |  |  | 
| Platelet count |  |  | 
| Transfusion Units |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unfractionated heparin, enoxaparin, low molecular weight heparin, bypass surgery, bleeding