Use of Low Molecular Weight Heparin (Tinzaparin) to Treat Blood Clots in Patients With Kidney Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
LEO Pharma
Information provided by (Responsible Party):
Wendy Lim, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00186745
First received: September 13, 2005
Last updated: February 12, 2013
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186745

Contacts
Contact: Wendy Lim, MD 905-521-6024 limwp@mcmaster.ca
Contact: Mark A Crowther, MD 905-521-6024 crowthrm@mcmaster.ca

Locations
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         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Heart and Stroke Foundation of Ontario
LEO Pharma
Investigators
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 July 23, 2014