Clinical trial NCT00420667: Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery
Official title: Effect of Low Molecular Weight Heparin vs Unfractionated Heparin on Bleeding After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Coronary Artery Bypass Grafting
Keywords: unfractionated heparin
enoxaparin
low molecular weight heparin
bypass surgery
bleeding
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 43
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Haemoglobin Concentration
measure: Haematocrit
measure: Platelet count
measure: Transfusion Units
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Institute of Cardiology - S. Camillo Hospital
state: CH
Study officials:
affiliation: Institute of Cardiology - G. d'Annunzio University, Chieti
name: Raffaele De Caterina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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