Embolism and Thrombosis Clinical Trial
Official title:
A Pilot Study of Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis of the Upper Extremity
Verified date | August 2017 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Anticoagulation with dalteparin and warfarin in patients with UEDVT secondary to central
venous catheters in patients with an active malignancy is an effective therapy as quantified
by the success of catheter preservation. A prolonged line salvage rate without a recurrence
of UEDVT will improve the management of cancer patients who develop upper extremity deep
venous thrombosis in the setting of a central venous (CV) catheter.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 2006 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Care Centre | Halifax | Nova Scotia |
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Sir Mortimer B. Davis Jewish General Hospital | Montreal | Quebec |
Canada | Ottawa Civic Hospital | Ottawa | Ontario |
Canada | Ottawa General Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Pfizer |
Canada,
Baarslag HJ, van Beek EJ, Koopman MM, Reekers JA. Prospective study of color duplex ultrasonography compared with contrast venography in patients suspected of having deep venous thrombosis of the upper extremities. Ann Intern Med. 2002 Jun 18;136(12):865-72. Erratum in: Ann Intern Med. 2003 Mar 4;138(5):438. — View Citation
Elliott G. Upper-extremity deep vein thrombosis. Lancet. 1997 Apr 26;349(9060):1188-9. — View Citation
Kommareddy A, Zaroukian MH, Hassouna HI. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2002 Feb;28(1):89-99. Review. — View Citation
Kooij JD, van der Zant FM, van Beek EJ, Reekers JA. Pulmonary embolism in deep venous thrombosis of the upper extremity: more often in catheter-related thrombosis. Neth J Med. 1997 Jun;50(6):238-42. — View Citation
Kovacs MJ, Anderson DA, Wells PS. Prospective assessment of a nomogram for the initiation of oral anticoagulation therapy for outpatient treatment of venous thromboembolism. Pathophysiol Haemost Thromb. 2002 May-Jun;32(3):131-3. — View Citation
Monreal M, Davant E. Thrombotic complications of central venous catheters in cancer patients. Acta Haematol. 2001;106(1-2):69-72. Review. — View Citation
Monreal M, Raventos A, Lerma R, Ruiz J, Lafoz E, Alastrue A, Llamazares JF. Pulmonary embolism in patients with upper extremity DVT associated to venous central lines--a prospective study. Thromb Haemost. 1994 Oct;72(4):548-50. — View Citation
Savage KJ, Wells PS, Schulz V, Goudie D, Morrow B, Cruickshank M, Kovacs MJ. Outpatient use of low molecular weight heparin (Dalteparin) for the treatment of deep vein thrombosis of the upper extremity. Thromb Haemost. 1999 Sep;82(3):1008-10. — View Citation
Volturo GA, Repeta RJ Jr. Non-lower extremity deep vein thrombosis. Emerg Med Clin North Am. 2001 Nov;19(4):877-93, vi. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint of the study will be rate of central line failure, defined as infusion failure that does not respond to 2mg tissue plasminogen activator (tPA), within the 3 months of study follow-up. | |||
Secondary | The secondary endpoints include recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE), major bleeding and death, time to central line failure. |
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