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Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

G

G. d'Annunzio University

Status

Completed

Conditions

Coronary Disease
Coronary Artery Bypass Grafting

Treatments

Drug: Enoxaparin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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