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

NCT00186745 | Terminated

• 1 other identifier: NA 5723
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Venous Thrombosis; Pulmonary Embolism

Keywords

Venous thrombosis; Pulmonary embolism; Kidney failure; Anticoagulants; Heparin, Low-Molecular-Weight

Outcome Measures

Primary Outcomes (1)

• Anti-Xa level measured on any two of Days 3, 5 or 7 of treatment

  Up to 7 days of treatment

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Tinzaparin DRUG

Dose: 175 IU/kg subcutaneously once daily, up to 7 days. Dose reduction as per protocol if anti-Xa levels exceed pre-defined limits.

Also known as: Brand name: Innohep

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Heart and Stroke Foundation of Ontario: collaborator
• LEO Pharma: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Renal Insufficiency

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Wendy Lim, MD

  St Joseph's Healthcare Hamilton / McMaster University

  PRINCIPAL INVESTIGATOR

• Mark A Crowther, MD

  St Joseph's Healthcare Hamilton / McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Medicine

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

CA (1)