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Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

Information source: G. d'Annunzio University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Disease; Coronary Artery Bypass Grafting

Intervention: Enoxaparin (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Chieti

Official(s) and/or principal investigator(s):
Raffaele De Caterina, MD, PhD, Principal Investigator, Affiliation: Institute of Cardiology - G. d'Annunzio University, Chieti

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Haemoglobin Concentration

Haematocrit

Platelet count

Transfusion Units

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

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Institute of Cardiology - S. Camillo Hospital, Chieti, CH 66100, Italy
Additional Information

Related publications:

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Goldman S, Zadina K, Moritz T, Ovitt T, Sethi G, Copeland JG, Thottapurathu L, Krasnicka B, Ellis N, Anderson RJ, Henderson W; VA Cooperative Study Group #207/297/364. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004 Dec 7;44(11):2149-56.

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Sirvinskas E, Veikutiene A, Grybauskas P, Cimbolaityte J, Mongirdiene A, Veikutis V, Raliene L. Influence of aspirin or heparin on platelet function and postoperative blood loss after coronary artery bypass surgery. Perfusion. 2006 Jan;21(1):61-6.

Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):188S-203S.

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Jones HU, Muhlestein JB, Jones KW, Bair TL, Lavasani F, Sohrevardi M, Horne BD, Doty D, Lappe DL. Preoperative use of enoxaparin compared with unfractionated heparin increases the incidence of re-exploration for postoperative bleeding after open-heart surgery in patients who present with an acute coronary syndrome: clinical investigation and reports. Circulation. 2002 Sep 24;106(12 Suppl 1):I19-22.

Burger W, Chemnitius JM, Kneissl GD, Rücker G. Low-dose aspirin for secondary cardiovascular prevention - cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis. J Intern Med. 2005 May;257(5):399-414. Review.

Sun JC, Crowther MA, Warkentin TE, Lamy A, Teoh KH. Should aspirin be discontinued before coronary artery bypass surgery? Circulation. 2005 Aug 16;112(7):e85-90.

Starting date: November 2004
Last updated: January 8, 2007

Page last updated: August 20, 2015

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