Safety profile of innohep versus subcutaneous unfractionated Heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis - innohep in Renal Insufficiency Study (IRIS)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

1. Following receipt of verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out
2. Patients with a symptomatic and objectively confirmed VTE (lower limb DVT or 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 hours prior to randomisation)
3. Patients with an indication for DVT treatment with SC LMWH or UFH followed by OAC for at least 90 Days
4. Hospitalised patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in hospital or in an out-patient setting
5. Patients at or more than 70 years with a creatinine clearance = 30 mL/min calculated according to the Cockcroft-Gault formula or
Patients at or more than 75 years with a creatinine clearance = 60 mL/min calculated according to the Cockcroft-Gault formula
6. Male or female
7. Any ethnic origin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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
2. Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
3. Patients with a symptomatic VTE requiring thrombolytic therapy or invasive intervention
4. End Stage Renal Disease patients requiring dialysis
5. Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
6. Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40/70 at randomisation and during the SC anticoagulant treatment period
7. Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)
8. Patients with a platelet count < 100.000.000.000/L
9. Patients with a known history of heparin-induced thrombocytopenia
10. Patients with known severe hepatic insufficiency manifested in a INR = 1,5
11. Patients with an uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg at at least 2 measurements within 24 hours prior to randomisation
12. Patients with ischaemic stroke at or within the last 1 week prior to randomisation
13. Patients with a known haemorrhagic stroke within 3 months prior to randomisation
14. Patients with a known bacterial endocarditis within 3 months prior to randomisation
15. Known or suspected hypersensitivity to component(s) of Investigational Products.
16. Current participation in any other interventional clinical trial
17. Patients who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 1 month
18. Patients previously randomised in this trial
19. Patients known or suspected of not being able to comply with the trial protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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