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Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
G. d'Annunzio University
ClinicalTrials.gov Identifier:
NCT00420667
First received: January 8, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention
Coronary Disease
Coronary Artery Bypass Grafting
Drug: Enoxaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Low Molecular Weight Heparin vs Unfractionated Heparin on Bleeding After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by G. d'Annunzio University:

Primary Outcome Measures:
  • Haemoglobin Concentration
  • Haematocrit
  • Platelet count
  • Transfusion Units

Estimated Enrollment: 40
Study Start Date: November 2004
Estimated Study Completion Date: May 2005
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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00420667

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

Publications:

ClinicalTrials.gov Identifier: NCT00420667     History of Changes
Other Study ID Numbers: 001
Study First Received: January 8, 2007
Last Updated: January 8, 2007
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 27, 2014