Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
Brief Summary: The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).

The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.


Options:
A: Inclusion Criteria:

* Confirmed diagnosis of acute proximal DVT based on contrast-enhanced Multi detector-row CT (MDCT) (not more than 10 days after the onset of the symptoms of DVT)
* Age:20 years
* Gender: No restriction
* Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period
* Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent

Exclusion Criteria:

* Symptomatic PE
* Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current DVT
* Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present
* Anticoagulant therapy for at least 24 hours to treat the current episode prior to entry into the study
* Active, clinically significant bleeding
* Thrombocytopenia (platelet count \<10×10⁴/µL at screening)
* Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension, or severe diabetes) or bleeding tendency
* Severe hepatic disorder
* Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
* Previous history of cerebral hemorrhage
* Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
* Previous history of Heparin-induced thrombocytopenia
* Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant)
* Severe renal disorder (serum creatinine \>2.0 mg/dL \[180 µmol/L\] at screening) in a well hydrated subject
* QT interval prolonged (QT interval corrected by Bazett's formula \[QTcB\] ≥450 msec; for patients with bundle branch block QTcB ≥480 msec) at screening
* Documented hypersensitivity to contrast media
* Use of any contraindicated drug that cannot be combined with the injection of contrast medium \[e.g., antihyperglycemics, such as biguanides (metformin hydrochloride, buformin hydrochloride)\]
* Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
* Previous participation in a study of GSK576428 \[Fondaparinux Sodium; including the studies of Org31540/SR90107A (ex-project code)\] or previous exposure to the therapeutic dose of GSK576428
* Drug or alcohol abuse
* Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
* Recent surgery within 3 days prior to entry into the study
* Life expectancy \<3 months
* Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
* Others whom the investigator or subinvestigator considers not eligible for the study
B: Inclusion Criteria:

* A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)

Exclusion Criteria:

* Contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours)
* Active Bleeding process
* Comorbid condition limiting expected survival to less than 3 months
* Current treatment with therapeutic dose of UFH, LMWH, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours
* Currently on long term warfarin or heparin therapy
* Allergy to heparin or history of heparin induced thrombocytopenia
* Currently pregnant
* Contraindication to contrast media (eg: allergy or creatinine \>200 umol/L).
* Currently enrolled or will be enrolled in a competing study
* Geographically inaccessible for follow-up assessment
C: Inclusion Criteria:

* Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation)
* Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days
* Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting
* Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula
* Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula

Exclusion Criteria:

* Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation
* Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
* Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention
* End stage renal disease patients requiring dialysis
* Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
* Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period
* Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)
* Patients with a platelet count \< 100 x 10 9/L
* Patients with a known history of heparin-induced thrombocytopenia
* Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5
* Patients with uncontrolled severe hypertension i.e. a systolic blood pressure \> 220 mm Hg or diastolic blood pressure \> 120 mm Hg during at least 2 measurements within 24 hours prior to randomisation
* Patients with ischaemic stroke at or within last 1 week prior to randomisation
* Patients with a known haemorrhagic stroke within 3 months prior to randomisation
* Patients with known bacterial endocarditis within 3 months prior to randomisation
D: Inclusion Criteria:

* Subjects with a confirmed diagnosis (by Multi detector-row CT \[MDCT\]) of acute symptomatic PE who are hemodynamically stable (i.e., the condition where anticoagulant therapy alone are indicated) (the time from onset should be no longer than 5 days, and subjects with or without symptomatic DVT are eligible)
* Age: \>=20 years
* Gender: No restriction Female subjects must either be of non-childbearing potential (post-menopausal \>1 year, hysterectomy, or sterilization), or of childbearing potential, has a negative pregnancy test at screening, and agree to use contraception throughout the study period.
* Hospitalization status: Subjects who are able to stay at the hospital at least during the initial treatment period.
* Written informed consent from the subject him/herself or his/her legally acceptable representative. Written informed consent from the subject's legally acceptable representative must be obtained if the subject is incapable of giving consent.

Exclusion Criteria:

* Shock or hemodynamic instability\*.

  \*: Defined as shock or decreased blood pressure (systolic blood pressure \<90 mmHg or \>=40 mmHg) lasting for at least 15 minutes and does not represent hemodynamically unstable conditions due to newly emergent arrhythmia, dehydration or sepsis.
* Right cardiac function failure detected by echocardiography at screening.
* Requirement for surgical thrombectomy, catheter intervention and thrombolytic therapy for the current PE.
* Subjects (for example, with free-floating thrombus in the femoral vein or ilium by MDCT at screening) for whom insertion of inferior vena cava filter is indicated or subjects in whom inferior vena cava filter is present.
* Prior to entry into the study, therapeutic dosage of anticoagulants for more than 24 hours to treat the current episode.
* Active, clinically significant bleeding
* Thrombocytopenia (platelet count \<10×10⁴/µL at screening)
* Concurrent conditions with bleeding risk (e.g., ulcer of the gastrointestinal tract, diverticulitis of the gastrointestinal tract, colitis, acute bacterial endocarditis, severe hypertension\*, or severe diabetes) or bleeding tendency.

  \*: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
* Severe hepatic disorder
* Known hypersensitivity to heparin, low-molecular-weight heparin (LMWH) or warfarin
* Previous history of cerebral hemorrhage
* Brain, spinal, or ophthalmological surgery within 3 months prior to entry into this study
* Previous history of Heparin-induced thrombocytopenia
* Patients for whom anticoagulant therapy is contraindicated or who cannot be taken off anticoagulant therapy due to coexistent condition (e.g. prosthetic heart valve implant).
* Severe renal disorder (serum creatinine \>2.0 mg/dL \[180 µmol/L\] at screening) in a well hydrated subject
* Documented hypersensitivity to contrast media
* Use of any contraindicated drug that cannot be combined with the injection of contrast medium \[e.g., antihyperglycemic metformin hydrochloride (Glycoran®, Melbin®)\]
* Participation in any other therapeutic drug study or a clinical study within 6 months prior to entry into this study
* Previous participation in a study of GSK576428
* Drug or alcohol abuse
* Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
* Recent surgery within 3 days prior to entry into the study
* Life expectancy \<3 months
* Pregnant women, nursing mothers, women who may be pregnant, or women contemplating pregnancy during the study period
* Others whom the investigator or subinvestigator considers not eligible for the study

Answer: C