Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Brief Summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.


Options:
A: 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
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

Inclusion criteria (selected):

* Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
* Written Informed Consent

Exclusion criteria

Exclusion criteria (selected):

* Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
* Active malignant disease or current cytostatic treatment
* Known severe renal insufficiency
* Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal
* Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
* Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control
* Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
* Contraindications to enoxaparin
* Participation in a clinical trial during the last 30 days
D: Key Inclusion Criteria

* Patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (TKR) or a revision of at least 1 component of a TKR
* Patients willing and able to undergo bilateral ascending contrast venography

Key Exclusion Criteria

* Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative
* Known or suspected history of heparin-induced thrombocytopenia
* Known coagulopathy
* Active bleeding or at high risk for bleeding
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
* Active hepatobiliary disease
* Alcohol and/or substance abuse within the past year
* Any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated
* Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm Hg or supine diastolic blood pressure \>105 mm Hg
* Clinically significant laboratory abnormalities at the enrollment visit:

  * Hemoglobin \<10 g/dL
  * Platelet count \<100,000/mm\^3
  * Creatinine clearance \<30 mL/min, as estimated by the method of Cockcroft and Gault
  * Alanine aminotransferase or aspartate aminotransferase level \>2\*upper limit of normal (ULN) or a total bilirubin ≥1.5\*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)

Answer: C