EUCTR2010-019200-23-DEActive, not recruitingNot Applicable
A multi-center, prospective, open-label, 8-weeks study to investigate the efficacy, safety and pharmacokinetics of certoparin (3000 IU anti-Xa bolus, with the option to titrate dose) in the prophylaxis of clotting in the extracorporeal circuit in patients undergoing chronic hemodialysis
ovartis Pharma GmbH0 sitesStarted: May 18, 2010Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Ambulatory patients =18 years, of either sex
- •2.Established end stage chronic kidney failure (CKF), requiring stable hemodialysis therapy (2-3 times per week)
- •3.Chronic hemodialysis therapy (including hemodiafiltration and hemofiltration) of at least 4h duration per session, for at least 3 months
- •4.Indication for anticoagulation during hemodialysis
- •5.Hemoglobin =10.0 g/dL at visit 1
- •6.Written informed consent given by the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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.Hypersensitivity/allergy to one of the components of the study drug (including chlorocresol) or to drugs with similar chemical structures
- •2.History of clinically significant bleeding within the last 4 weeks
- •3. Acute or chronic illness that can change the blood coagulation, or aggravate or terminate the clinical picture, such as peptic ulcer, active symptomatic diverticulitis, or cancer
- •4.Genetic abnormality of the clotting system (congenital bleeding disorder such as hemorrhagic diathesis, deficiency of coagulation factors, severe thrombocytopenia or otherwise increased bleeding risk)
- •5.Prior major surgery, trauma or invasive procedure of the central nervous system
- •6. Any prior major surgery, trauma or invasive procedure within the last 4 weeks
- •7.Acute or history of heparin induced thrombocytopenia type II (HIT II)
- •8.CRP > 300 mg/l
- •9.Acute severe infection (e.g. endocarditis, pneumonia, sepsis)
- •10.Target blood flow in device less than 200 ml/min. This holds for inclusion time point and during the study.
- •11.Patients using the following medicines: Dextran 40, chronic systemic glucocorticoids (= 4 months), thrombolytic agents and anticoagulants (e.g. phenprocoumon), glycoprotein IIb / IIIa antagonists. This holds for inclusion time point and during the study, see 6.7.5.
- •12.LMWH/heparin administration on three or more consecutiv days in the 5 days prior to inclusion
- •13.Immobilization due to cast or fracture
- •14.Life expectancy < 6 months or illness with very high acute mortality (> 30% per year)
- •15.Acute symptomatic DVT / PE
- •16.Acute or history of non-hemorrhagic stroke (< 3 months); hemorrhagic stroke or intracranial bleeding (< 12 months) or stroke for which thrombolytic therapy is planned
- •17.Acute or ongoing intracranial disease, e.g. cerebral aneurysm
- •18.Spinal or epidural anesthesia, lumbar punction within the last 12 hours
- •19.Uncontrolled hypertension, defined as diastolic blood pressure > 105 mmHg
- •20.Severe liver disease
- •21.Retinopathy, intravitreal or other intraocular bleeding or eye/ear injury
- •22.Participation in another clinical trial within the last 30 days
- •23.Subjects unlikely to comply with the requirements of the protocol.
- •who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
- •owho are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion
Investigators
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