Please select the eligibility criteria that correspond to the clinical trial below.
Title: Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery
Brief Summary: (i) Main Research Question(s): What is the effect of fondaparinux on coronary graft patency, heart attack, stroke, and death in patients who have undergone coronary artery bypass grafting (CABG)? To reliably answer this question requires a large randomised trial. We propose a pilot study to demonstrate the feasibility of recruiting patients into this study and of performing CT angiograms to measure graft patency at 30 days.

(ii) Why is this research important? Coronary artery bypass surgery has made a very important contribution to improving the health and survival of patients with advanced coronary artery disease but still has many problems. One in 10 patients experiences a heart attack at the time of surgery, 1 in 20 experiences a heart attack, stroke, or death during hospitalization, and 1 in 4 patients has at least 1 blocked graft within 1 year of surgery. Fondaparinux, a relatively new anticoagulant drug, has been shown to significantly reduce cardiovascular events and death in patients who have suffered a recent heart attack. Compared to established anticoagulant therapies for acute myocardial infarction, fondaparinux has been shown to be more effective with similar or lower risks of bleeding.

Fondaparinux, unlike the most commonly used anticoagulants, does not cause Heparin Induced Thrombocytopenia (HIT), a rare condition with extremely high morbidity and mortality.

This drug has never been studied in CABG patients. Our pilot study will provide key information about feasibility that will help us to design and perform a large definitive study in the future.

(iii) What is being studied? We will be looking at blood flow in bypass grafts, heart attack, stroke, venous thromboembolism and death. For safety we will be looking at bleeding, transfusion, and need for further surgery because of bleeding. We will also perform laboratory tests for HIT antibodies as their levels are prognostic for the development of HIT and are also related to morbidity and mortality. The incidence of actual HIT cases will also be recorded.


Options:
A: Inclusion Criteria:

1. Patient is scheduled to have a Fontan or modified Fontan procedure

Exclusion Criteria:

1. Requirement for long-term anticoagulation (e.g., prosthetic heart valve, active DVT)
2. Risk of significant bleeding or any other known medical contraindication to Heparin, Warfarin, or ASA.
3. Inability to supervise therapy due to social or geographical reasons.
4. Pregnancy or potential pregnancy during study period
B: Inclusion Criteria:

* Patients who are scheduled for elective Cardiac or Thoracic Surgery.
* Age \> 18 years of age.

Exclusion Criteria:

* Patients with a clinical suspicion or a documented history of DVT/PE
* Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)
* Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.
* Documented allergy to heparin, desirudin, or lepirudin
* Patients with a history of coagulation disorder
* Platelet count\< 100 X109 /dl
* Active bleeding
* Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min
* Patients with a baseline coagulopathy (INR \> 1.5 or aPTT \> 45 sec)
* Patients with liver disease
* Pregnancy
* Patients who require ventricular assist devices before or after surgery
C: Inclusion Criteria:

* Male or female
* At least 18 years of age
* Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
* Subject had a baseline ATIII level of less than 100% and equal to or above 60%
* Subject signed the informed consent form
* Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study

Exclusion Criteria:

* Documented congenital ATIII deficiency or ATIII levels below 60%
* Subject had a baseline ATIII level of 100% or higher
* Subject needed emergency (non-elective) surgery
* Subject needed heart transplantation
* History of anaphylactic reaction(s) to blood or blood components
* Allergies to excipients
* Subject was pregnant
* Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
* Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment
* Subject had participated in any another investigational study within the last 30 days previous to the inclusion
D: Inclusion Criteria:

* age at least 18 years
* undergoing first ever multivessel CABG-only surgery with at least 2 free grafts (e.g. Radial artery, saphenous vein, free internal mammary artery)
* undergoing CABG with cardiopulmonary bypass

Exclusion Criteria:

* clear indication for anticoagulation (e.g. prosthetic heart valve replacement, recurrent DVT)
* allergy or intolerance of fondaparinux or unfractionated heparin
* renal failure or other contraindication for coronary artery graft CT angiogram
* inability to provide informed consent

Answer: D