Use of Low Molecular Weight Heparin (Tinzaparin) to Treat Blood Clots in Patients With Kidney Failure
Launched by ST. JOSEPH'S HEALTHCARE HAMILTON · Sep 13, 2005
Trial Information
Current as of June 01, 2025
Terminated
Keywords
ClinConnect Summary
Background and rationale. Venous thromboembolism (VTE) is an important clinical problem because it is common, preventable, contributes to morbidity and mortality, and is costly. Low molecular weight heparin (LMWH) is the preferred anticoagulant for VTE treatment, but is renally excreted. Consequently, LMWH use in patients with renal insufficiency may result in accumulation of the anticoagulant effects and the potential for avoidable bleeding complications. As a result, most patients with renal insufficiency who also have VTE are unable to benefit from LMWH treatment. These patients are ther...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients 18 years of age or older
- • Objectively confirmed VTE requiring anticoagulant therapy, including lower extremity and upper extremity deep vein thrombosis (catheter and non-catheter related, including dialysis access thrombosis \[i.e., graft, fistula\]); peripheral vein thrombosis (e.g., portal vein, mesenteric vein, cerebral vein thrombosis), and pulmonary embolism
- Exclusion Criteria:
- • Weight exceeding 105 kg
- • Unstable declining renal function, defined as documented change in creatinine \> 20% in the past 3 months or clinical circumstances likely to be associated with change in renal function, such as dehydration or severe intercurrent illness. Where no previous creatinine values exist and the patient is otherwise stable, patients will not be excluded on the basis of unknown previous renal function.
- • Known allergy to heparin/LMWHs or history of heparin induced thrombocytopenia
- • Treatment with UFH, LMWH, danaparoid, oral direct thrombin inhibitors for \>48 h
- • Bleeding requiring hospitalization or blood transfusion within 6 months(exception is blood transfusion given in relation to surgical procedures within 6 months)
- • History of intracerebral hemorrhage
- • Known active liver disease (AST or ALT \> 3 times the upper limit of normal, or bilirubin \> 50 umol/L)
- • Known active peptic ulcer disease, with ongoing symptoms or need for anti-ulcer medical therapy
- • Thrombocytopenia (platelet count of \< 100 x 109/L)
- • Ongoing need for antiplatelet agents (clopidogrel, ticlopidine, aspirin \> 325 mg daily)
- • Pregnancy or lactation
- • Geographic inaccessibility
- • Unable, or unwilling, to provide written informed consent
About St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton is a leading academic health sciences organization dedicated to advancing patient care through innovative research and clinical trials. With a strong commitment to excellence in healthcare delivery, the institution integrates research, education, and community service to enhance the health and well-being of the populations it serves. St. Joseph's Healthcare Hamilton emphasizes collaboration across disciplines and partners with various stakeholders to facilitate groundbreaking studies in diverse medical fields, fostering a culture of discovery and improving treatment outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hamilton, Ontario, Canada
Patients applied
Trial Officials
Wendy Lim, MD
Principal Investigator
St Joseph's Healthcare Hamilton / McMaster University
Mark A Crowther, MD
Principal Investigator
St Joseph's Healthcare Hamilton / McMaster University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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