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Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00420667
Enrollment
43
Registered
2007-01-11
Start date
2004-11-30
Completion date
2005-05-31
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Grafting, Coronary Disease

Keywords

unfractionated heparin, enoxaparin, low molecular weight heparin, bypass surgery, bleeding

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.

Interventions

DRUGEnoxaparin

Sponsors

G. d'Annunzio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Haemoglobin Concentration
Haematocrit
Platelet count
Transfusion Units

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026