Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: Inclusion Criteria:

* Consecutive patients who had
* planned laparoscopic surgery for
* colorectal cancer will be included in the study provided no exclusion criteria will be found

Exclusion Criteria:

* age \< 18 years
* surgery for non-cancer disease
* duration of surgery \< 45 min
* other indication for anticoagulant therapy
* known cerebral metastases
* kidney or liver failure
* known hemorrhagic diathesis or high risk for bleeding
* history of intracerebral bleeding or neurosurgery within 6 months, history of heparin induced thrombocytopenia
* pregnancy or lactation
* refusal of informed consent.
B: Inclusion Criteria:

* Patients with a diagnosis of active cancer.
* Symptomatic and objectively confirmed VTE.
* ≥ 18 years of age or above the legal age of consent as per country specific regulations.
* Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Signed informed consent.

Exclusion Criteria:

* Life expectancy \< 6 months.
* Patients with basal cell carcinoma or non-melanoma skin cancer.
* Creatinine clearance ≤ 20 ml/min.
* Contra-indications to anticoagulation.
* Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
* History of heparin-induced thrombocytopenia (HIT).
* Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
* Patients unlikely to comply with the protocol.
* Participation in another interventional study.
* Pregnant or breast-feeding women.
* Women of childbearing potential.
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: Inclusion Criteria:

* ambulatory patients with histologically confirmed advanced adenocarcinoma of the pancreas
* no previous radio- or chemotherapy
* Karnofsky Performance Status (KPS) ≥ 60%
* measurable tumour lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within the last 14 days
* no VTE within the last 2 years
* adequate compliance and home residence within geographical proximity to the particular department (allowing an adequate follow-up)
* sufficient bone marrow function (leukocytes 3.5 × 109/l, thrombocytes 100 × 109/l)
* age ≥ 18 years.

Exclusion Criteria:

* pre-existing indication for anticoagulation
* major bleeding events within the last 2 weeks
* severe impairment of coagulation
* active gastrointestinal ulcers or major surgery within the last 2 weeks
* body weight \< 45kg or \> 100kg
* pregnancy/lactation or insufficient contraception during study
* severely impaired renal function (creatinine clearance \< 30 ml/min)

Answer: B