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OpenTrials
Completed

NCT Number: NCT00420667

Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Coronary Artery Bypass Grafting Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Cardiology - S. Camillo Hospital

Chieti, CH, 66100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enoxaparin

Drug

Primary outcomes

  1. Haemoglobin Concentration

  2. Haematocrit

  3. Platelet count

  4. Transfusion Units

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 11, 2007
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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