Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
Condition: Deep Vein Thrombosis
MeSH terms: Renal Insufficiency; Thrombosis; Venous Thrombosis
Intervention: innohep®; Heparin
Intervention description: 175 anti-Xa IU/kg administered subcutaneously (SC) once daily; Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
Intervention MeSH terms: Heparin; Tinzaparin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 541.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Acute, symptomatic and objectively confirmed DVT

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.
    

Eligibility criteria:

        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