Use of Low Molecular Weight Heparin (Tinzaparin) to Treat Blood Clots in Patients With Kidney Failure
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 thinners, or anticoagulants. The preferred treatment is an anticoagulant known as low molecular weight heparin (LMWH). LMWH is given by an injection under the skin, which is convenient for patients because they can self-administer this medication at home, and no blood testing is required. However, LMWH is cleared from the body through the kidneys, so patients who have kidney failure are generally not treated with LMWH because they may be at a higher risk of bleeding.
One type of LMWH, known as tinzaparin, may be less dependent on the kidneys for clearance and may not increase in patients with kidney failure. The investigators would like to use tinzaparin to treat patients who have deep vein thrombosis or pulmonary embolism, and who also have kidney failure.
The purpose of this study is to determine whether the blood thinning effects of tinzaparin build up, or accumulate, in patients with varying degrees of kidney failure compared to patients without kidney failure. The blood thinning effects will be measured using a blood test known as an anti-Xa level. Patients will be followed over the time they receive tinzaparin and those patients who are found to have potentially high levels of tinzaparin (based on the anti-Xa level) will have their tinzaparin dose adjusted. The investigators believe that the levels of tinzaparin will not accumulate to potentially dangerous levels in a significant number of patients with kidney failure.
| Condition | Intervention |
|---|---|
|
Venous Thrombosis Pulmonary Embolism |
Drug: Tinzaparin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tinzaparin for Treatment of Venous Thromboembolism in Renal Insufficiency: A Pilot Study |
- Anti-Xa level measured on any two of Days 3, 5 or 7 of treatment [ Time Frame: Up to 7 days of treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
All patients in this cohort receive treatment with weight-adjusted, standard-dose tinzaparin for treatment of venous thromboembolism. Trough anti-Xa level measurements done on any 2 of days 3, 5 or 7 of treatment. Patients with a trough anti-Xa level > 0.5 IU/mL receive dose adjustment of the tinzaparin.
|
Drug: Tinzaparin
Dose: 175 IU/kg subcutaneously once daily, up to 7 days. Dose reduction as per protocol if anti-Xa levels exceed pre-defined limits.
Other Name: Brand name: Innohep
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Wendy Lim, MD | 905-521-6024 | limwp@mcmaster.ca |
| Contact: Mark A Crowther, MD | 905-521-6024 | crowthrm@mcmaster.ca |
| Canada, Ontario | |
| St Joseph's Healthcare Hamilton | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Wendy Lim, MD 905-521-6024 limwp@mcmaster.ca | |
| Contact: Mark Crowther, MD 905-521-6024 crowthrm@mcmaster.ca | |
| Principal Investigator: Wendy Lim, MD | |
| Principal Investigator: | Wendy Lim, MD | St Joseph's Healthcare Hamilton / McMaster University |
| Principal Investigator: | Mark A Crowther, MD | St Joseph's Healthcare Hamilton / McMaster University |
More Information
No publications provided
| Responsible Party: | Wendy Lim, Associate Professor, Department of Medicine, St. Joseph's Healthcare Hamilton |
| ClinicalTrials.gov Identifier: | NCT00186745 History of Changes |
| Other Study ID Numbers: | NA 5723 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by St. Joseph's Healthcare Hamilton:
|
Venous thrombosis Pulmonary embolism Kidney failure Anticoagulants Heparin, Low-Molecular-Weight |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Renal Insufficiency Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Kidney Diseases Urologic Diseases |
Thromboembolism Heparin, Low-Molecular-Weight Dalteparin Tinzaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013