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:

* 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
B: Inclusion Criteria:

* men and non-pregnant, non-breastfeeding women
* 40 years or older
* hospitalized with congestive heart failure or acute respiratory failure
* infection (without septic shock)
* acute rheumatic disorder
* inflammatory bowel disease

Exclusion Criteria:

* patients with venous thromboembolism (VTE)
* active bleeding or at high risk of bleeding
* unable to take oral medication
* with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.
C: Inclusion Criteria:

1. Hospitalized medical patients 70 years of age or older
2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
3. written informed consent

Exclusion Criteria:

1. immobilization longer than 3 days prior to randomization
2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
3. expected major surgical or invasive procedure within the next 3 weeks after randomization
4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
5. immobilization due to cast or fracture
6. indication for anticoagulatory or thrombolytic therapy
7. acute symptomatic DVT / PE
8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures
9. Acute or history of heparin induced thrombocytopenia type II (HIT II)

Other protocol-defined inclusion/exclusion criteria may apply
D: List of inclusion and exclusion criteria

Inclusion Criteria:

* Hospitalization within 48 hours prior randomization for at least one of the following medical acute medical illness:

  * Acute decompensation of heart failure
  * Severe systemic infection and at least one of the following:

    * Chronic pulmonary diseases (COPD, pulmonary fibrosis, pulmonary restrictive syndrome...)
    * Obesity (BMI ≥ 30kg/m2)
    * Personal history of VTE
    * Age ≥ 60 years
  * Active cancer (defined as being histologically confirmed with an initial diagnosis or recurrence or metastasis within the past 6 months) excluding planned hospitalization for chemotherapy
* Anticipated duration of hospitalization at least 6 days
* Health status:

  * ASA Health status score ≤ 3 (American Society of Anesthesiologists)
  * ECOG ≤ 2 in cancer patient
* Anticipated life expectancy \> 1 week

Exclusion criteria:

* Major surgery or major trauma within the previous 6 weeks (orthopedic or trauma surgery to the lower extremities, gastrointestinal tract, urological, chest, gynecological surgery)
* Need for any ventilatory support (with intubation required)
* Symptomatic VTE at enrollment
* Multi organ failure
* Evidence of an active bleeding disorder
* Contraindication to anticoagulation:

  * Coagulopathy (acquired or inherited)
  * Neurosurgery within the past day 30
  * History of cerebral hemorrhage at any time
  * Known bacterial endocarditis
  * Uncontrolled arterial hypertension (systolic BP \> 200 mmHg or diastolic BP \> 110 mm Hg) at 2 successive readings
  * Haemostatic abnormalities: baseline platelet count \<50,000/mm3, activated partial thromboplastin time (aPTT) 1.5x the upper limit of normal, or International Normalized Ratio (INR) \> 1.5
  * Indication for thrombolytic therapy
  * Need for a curative treatment of anticoagulant therapy (low molecular weight heparin, unfractionated heparin, oral anticoagulant therapy)
  * Receiving LMWH or UFH at prophylactic doses for more than 72 hours prior to inclusion (patients receiving LMWH or UFH at prophylactic doses for 72 hours or less prior to entry may be included in the study)
  * Oral anticoagulant therapy within 72 hours prior to inclusion
* Cerebrovascular accident at inclusion and within 10 days prior study inclusion
* Prosthetic heart valves
* Confirmed cerebral metastases
* Known hypersensitivity to heparin or LMWH, or pork-derived products
* History of documented episode of heparin, or LMWH induced thrombocytopenia, and/or thrombosis (HIT, HAT, or HITTS)
* Participating in another clinical trial within the previous 30 days (patients with cancer included in a cancer treatment protocol are authorized to participate)
* Persistent renal failure (defined as a documented value of calculated creatinine clearance \< 30 mL/min on at least 2 occasions ³3 days prior to entry into the study)
* Known or suspected severe anemia of unexplained cause considered clinically relevant by investigator
* Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
* Unlikely to be compliant (e.g. alcohol, drug abuse)
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling to be tested for pregnancy (pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product)
* Refusal or inability to give informed consent to participate in the study
* Inability to be followed-up after discharge until day 90 after randomization

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Answer: A