A randomized, double-blind, multi-center comparison of the efficacy and safety of certoparin (3000 U anti-Xa o.d.) with unfractionated heparin (5000 IU t.i.d.) in the prophylaxis of thromboembolic events in acutely ill medical patients

• Conditions: acutely ill immobilized medical patients

• Registration Number: EUCTR2006-004676-12-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-25
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3200

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

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.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 3 weeks following randomization (e.g. thoracic surgery; but permitted are: e.g. uncomplicated angiography, gastroscopy)
4.patients with severe sepsis or need for ventilatory support (permitted are CPAP, oxygen via mask etc.)
5.LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
6.immobilization due to cast or fracture
7.indication for anticoagulatory or thrombolytic therapy
8.life expectancy < 6 months or illness with very high acute mortality (> 30%)
9.acute symptomatic DVT / PE
10.known hypersensitivity to any of the study drugs or drugs with similar chemical structures
11.Acute or history of heparin induced thrombocytopenia type II (HIT II)
12.hemorrhagic diathesis, deficiency of coagulation factors, severe thrombocytopenia
13.acute or history of non-hemorrhagic stroke (< 3 months); hemorrhagic stroke or intracranial bleeding (< 12 months)
14.acute or ongoing intracranial disease, e.g. cerebral aneurysm
15.high risk of gastrointestinal bleeding
16.spinal or epidural anesthesia, lumbar punction within the last 12 hours
17.uncontrolled hypertension, RRdiast. > 105 mmHg
18.severe liver disease
19.severe renal dysfunction (estimated GFR < 30 ml/min, Cockcroft-Gault or MDRD formula)
20.acute endocarditis
21.known active retinopathy, intravitreal or other intraocular bleeding
22.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
23.Subjects unlikely to comply with the requirements of the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified