Please select the eligibility criteria that correspond to the clinical trial below.
Title: RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.
Brief Summary: The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.


Options:
A: Inclusion Criteria:

* Male and female patients aged 18 years or above
* Patients scheduled for elective total hip replacement

Exclusion Criteria:

* Planned, staged total bilateral hip replacement
* Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
* Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
* Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
B: Inclusion Criteria:

* Male and female patients aged 18 years or above
* Patients scheduled for elective total hip replacement

Exclusion Criteria:

* Planned, staged total bilateral hip replacement
* Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
* Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
* Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
C: Inclusion criteria:

* Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty.
* Male or female 18 years of age or older.
* Patients giving written informed consent for study participation.

Exclusion criteria:

* Patients weighing less than 40 kg.
* History of bleeding diathesis.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period (see Section 4.2.2).
* Major surgery or trauma (e.g., hip fracture) within 3 months of enrolment.
* Recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment.
* Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, Atriovenous (AV) malformation or aneurysm.
* Ongoing treatment for Venous Thromboembolism (VTE).
* Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment.
* Gastric or duodenal ulcer within one year of enrolment.
* Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery.
* Active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or Alanine Aminotransferase (ALT) \>3 x ULN.
* Known severe renal insufficiency (CrCl \<30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. See Appendix 10.1 for calculation.
* Elevated creatinine that, in the investigators opinion, contraindicates venography.
* Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin \>162.5 mg/day or NSAID with t 1/2 \>12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed).
* Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb.
* Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who:

  * Are pregnant.
  * Are nursing.
  * Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility.
* Known allergy to radio opaque contrast media.
* History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count \<100,000 cells/microliter at randomisation.
* Allergy to heparins or dabigatran etexilate.
* Active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years.
* Participation in a clinical trial within 30 days of randomisation.
* Leg amputee.
* Known alcohol or drug abuse which would interfere with completion of the study.
* Contraindications to enoxaparin.
* Previous participation in this study.
D: Inclusion Criteria:

* First total knee joint replacement
* Signed informed consent

Non-inclusion Criteria:

* History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
* Active cancer
* Long-term anticoagulation

Answer: A