Status:
COMPLETED
The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Pfizer
Conditions:
Embolism and Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to obtain an estimate of catheter survival in the setting of upper extremity deep vein thrombosis (UEDVT) in patients treated with dalteparin and warfarin. Anticoagulatio...
Detailed Description
Deep venous thrombosis (DVT) is a serious disorder with an annual incidence of approximately 0.1% and increasing with age to 1% in the elderly. Deep venous thrombosis of the upper extremity (UEDVT) is...
Eligibility Criteria
Inclusion
- Males or females greater than or equal to 18 years of age, inclusive.
- Symptomatic acute upper limb thrombosis with or without pulmonary embolism associated with central venous catheter objectively documented by compression ultrasonography, venogram or computed tomography (CT) scan.
- Diagnosis of active malignancy, as defined by patients who are either receiving active treatment, or have metastatic disease or who have been diagnosed within the past two years.
- Willing to provide written informed consent.
Exclusion
- Dialysis catheters.
- Active bleeding or high risk for major bleeding.
- Platelet count \< 100 x 10x9/L.
- Serum creatinine \> 177umol/L
- Currently on warfarin with therapeutic intent (does not include minidose warfarin used as prophylaxis for CV catheter thrombosis).
- Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement.
- Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy.
- Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) with a bone marrow or stem cell transplant pending in next 3 months.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00216866
Start Date
September 1 2002
End Date
March 1 2006
Last Update
August 28 2017
Active Locations (6)
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1
Queen Elizabeth II Health Care Centre
Halifax, Nova Scotia, Canada, B3H 1Y8
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
3
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
4
Ottawa General Hospital
Ottawa, Ontario, Canada, KiY 4B1