Status:
TERMINATED
Use of Low Molecular Weight Heparin (Tinzaparin) to Treat Blood Clots in Patients With Kidney Failure
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
LEO Pharma
Conditions:
Venous Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Blood clots in the leg veins, known as deep vein thrombosis, are important because they may travel to the lung (known as pulmonary embolism) and cause death. Blood clots are treated with blood thinner...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00186745
Start Date
March 1 2005
End Date
February 1 2016
Last Update
April 19 2016
Active Locations (1)
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1
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6