Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization
Brief Summary: Primary objective:

* To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

* To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
* To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study
* To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

  * Major and minor hemorrhage
  * Heparin induced thrombocytopenia
  * Serious adverse events
* To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.


Options:
A: Inclusion Criteria:

* Male and female patients aged 40 years or more
* Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

  * Heart failure, New York Heart Association (NYHA) class III or IV
  * Active cancer
  * Acute ischemic stroke
  * Acute infectious and inflammatory diseases, including acute rheumatic diseases
  * Acute respiratory insufficiency
  * Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

* Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
* Conditions that may increase the risk of bleeding, including intracranial hemorrhage
* Required drugs or procedures which may interfere with the study treatment
* Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
* General conditions in which subjects are not suitable to participate in the study
B: Inclusion Criteria:

* ischemic stroke
* female or male gender
* mRS (modified Rankin Scale) 0-1 (min one month before the event)
* NIHSS ≥ 6 and ≤ 25
* Age: 18-80 years
* initiation of therapy in the interval from 4.5 to 24 hours from onset of symptoms of ischemic stroke
* focal neurological deficit of at least 30 min, which was significantly obviously does not disappear before treatment
* patient will participate voluntarily and signed informed consent. Informed consent will be obtained from each patient, guardian or close relative
* patients who are unable to sign, but who are able to understand what means to participate in the study, may give informed consent through eyewitness
* willingness and ability to comply with the protocol

Exclusion Criteria:

* intracranial hemorrhage confirmed by CT scan
* CT image heavy and extensive focal cerebral ischemia
* lacunar syndrome
* epileptic seizure at the beginning of ischemic stroke
* previous or planned treatment with intravenous, intra-arterial thrombolysis, mechanical recanalization or ultrasound assisted thrombolysis
* stroke, myocardial infarction, head trauma in the last 3 months
* tromboctov count below 100 000/mm ³
* therapeutically uncontrolled blood pressure: systolic blood pressure\> 185 mmHg or diastolic blood pressure\> 110 mmHg
* therapeutically uncontrolled blood glucose ˂ 2.77 or\> 22.15 mmol / l
* Known bleeding diathesis, other coagulopathies, severe hepatopathy, severe nephropathy
* patients receiving oral anticoagulants
* current or previous life-threatening bleeding
* major surgery less than 2 weeks ago
* known malignancy
* active TB
* pregnancy
* allergy to Heparin or Fraxiparine
* known alcohol abuse and / or drugs
* active participation in another clinical study
C: Inclusion criteria:

* Recent immobilization ≤ 3 days
* Level 1 mobility patients who are ≥ 40 years of age with acute medical illness or acute exacerbation of chronic medical illness
* Level 2 mobility patients who

  * are \>75 yrs of age
  * are ≥ 40 years of age and have a history of VTE (deep venous thrombosis or pulmonary embolism)
  * are ≥ 40 years of age and have a baseline diagnosis of cancer (active cancer or history of cancer)

Anticipated decreased level of mobility of 5 ± 2 days with a level of activity 1 and 2 at the time of study entry and likely to continue at a lower than pre-morbid activity level after the initial 5 ± 2 day period. PATIENTS DO NOT HAVE TO BE HOSPITALIZED IN ORDER TO BE INCLUDED IN THE STUDY.(Definition of decreased level of mobility: _Level 1:bed rest or sedentary patients _Level 2:level 1 with bathroom privileges)

* Presence of at least one of the following medical conditions:

  * Heart Failure, NYHA class III and IV

    * Class III : Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitationdyspnea, or anginal pain.
    * Class IV : Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
  * Acute respiratory insufficiency
  * Other acute medical conditions such as:

    * Acute ischemic stroke, any territory, with an appropriate neuroradiologic (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke
    * acute infection without septic shock
    * acute rheumatic disorders
    * active episode of inflammatory bowel disease
    * active cancer defined as history of histologically or cytologically confirmed cancer in patients who are not candidates for debulking or curative intent surgery at study entry
    * Any other acute medical illness or exacerbation of chronic medical illness resulting in clinically significant reduction in mobility as compared to premorbid level.

Exclusion criteria:

* Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception
* Patients with any evidence of an active bleeding disorder
* Contraindication to anticoagulation
* Major surgery within the previous 3 months
* Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
* Known hypersensitivity to heparin, or LMWH, or pork derived products
* A documented previous episode of heparin-induced or LMWH induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS)
* Patients who have taken part in another clinical trial within the previous thirty days
* Patients with a persistent renal failure. The patient's creatinine level must be less than the creatinine level per gender/age/weight. This will replace the calculated creatinine clearance
* Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator
* Patients with prosthetic heart valves
* Patients with known cerebral metastases
D: Inclusion criteria:

* Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke
* Onset of symptoms of qualifying stroke within 48 hours prior to randomization. In patients receiving thrombolytic therapy for the acute stroke, such as tissue-type plasminogen activator (tPA), administration of study drug may not start until at least 24 hours after completion of thrombolytic therapy
* Significant motor impairment of the leg, as indicated by a NIHSS score ≥2 on item 6
* Inability to walk without assistance

Exclusion criteria:

* Females who are pregnant, breast-feeding, or of childbearing potential and not using medically acceptable and effective contraception
* Clinical evidence of VTE at screening
* Any evidence of active bleeding on the basis of clinical judgment
* Prior history of intracranial hemorrhage (including that at screening)
* Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
* Thrombolytic therapy (e.g., tPA) or intra-arterial thrombolytic therapy within the preceding 24 hours.Thrombolytic therapy is permitted for treatment of the acute stroke but must have been completed 24 hours prior to randomization.
* Comatose at screening (NIHSS score ≥2 on item 1a)
* Known or suspected cerebral aneurysm or arteriovenous malformation
* Confirmed malignancy that may pose an increased risk for bleeding or otherwise compromise follow-up or outcome assessment (e.g., lung cancer)
* Impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited); baseline platelet count \<100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal; or international normalized ratio(INR) \>1.5
* Major surgery or recent major trauma within the previous 3 months
* Anticipated need for full-dose treatment with therapeutic levels of an anticoagulant (LMWH, UFH, oral anticoagulant), e.g., for cardiogenic source of embolism or dissection
* Treatment with a LMWH or UFH at prophylactic dose for more than 48 hours prior to randomization(patients receiving LMWH or UFH less than 48 hours prior to randomization may be randomized)
* Allergy to heparin or enoxaparin sodium, or known hypersensitivity to heparin, enoxaparin, or pork products
* History of heparin or enoxaparin induced thrombocytopenia and/or thrombosis (heparin-induced thrombocytopenia \[HIT\], heparin-associated thrombocytopenia \[HAT\], or heparin-induced thrombotic thrombocytopenia syndrome \[HITTS\])
* History of hypersensitivity to iodinated contrast media and/or iodine
* Bacterial endocarditis
* Prosthetic heart valve
* Known or suspected severe anemia (Hg \<10.0 g/dL)
* Uncontrolled arterial hypertension (systolic blood pressure \[BP\] \>180 mmHg or diastolic BP \>100 mmHg) at the time of randomization or clinical hypertensive urgency
* Any other clinically relevant serious diseases, including severe liver disease or renal failure \[creatinine clearance \<30 mL/min on at least two occasions\].
* Treatment with other investigational agents or devices within the previous 30 days, planned use of other investigational drugs or devices, or previous enrollment in this study.

Answer: C