Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420667
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : January 11, 2007
Information provided by:
G. d'Annunzio University

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Coronary Artery Bypass Grafting Drug: Enoxaparin Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Low Molecular Weight Heparin vs Unfractionated Heparin on Bleeding After Cardiac Surgery
Study Start Date : November 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin
U.S. FDA Resources

Primary Outcome Measures :
  1. Haemoglobin Concentration
  2. Haematocrit
  3. Platelet count
  4. Transfusion Units

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

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 identifier (NCT number): NCT00420667

Institute of Cardiology - S. Camillo Hospital
Chieti, CH, Italy, 66100
Sponsors and Collaborators
University of Chieti
Principal Investigator: Raffaele De Caterina, MD, PhD Institute of Cardiology - G. d'Annunzio University, Chieti

Publications: Identifier: NCT00420667     History of Changes
Other Study ID Numbers: 001
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

Keywords provided by G. d'Annunzio University:
unfractionated heparin
low molecular weight heparin
bypass surgery

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action