The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis

NCT00216866 | Completed Phase 2

• 1 other identifier: R-02-191
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 6

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. 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.

Conditions

Embolism and Thrombosis

Keywords

Embolism; Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary endpoints include recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE), major bleeding and death, time to central line failure.

Interventions

Dalteparin DRUG

Warfarin DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Pfizer: collaborator

Study Sites (6)

Queen Elizabeth II Health Care Centre

Halifax, Nova Scotia, B3H 1Y8, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, KiY 4B1, Canada

Location

Ottawa Civic Hospital

Ottawa, Ontario, KiY 4E9, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (9)

• Kommareddy A, Zaroukian MH, Hassouna HI. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2002 Feb;28(1):89-99. doi: 10.1055/s-2002-20567.

  PMID: 11885029 BACKGROUND

• 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. doi: 10.1016/s0300-2977(97)00020-x.

  PMID: 9232088 BACKGROUND

• 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.

  PMID: 7878630 BACKGROUND

• Volturo GA, Repeta RJ Jr. Non-lower extremity deep vein thrombosis. Emerg Med Clin North Am. 2001 Nov;19(4):877-93, vi. doi: 10.1016/s0733-8627(05)70224-8.

  PMID: 11762277 BACKGROUND

• Monreal M, Davant E. Thrombotic complications of central venous catheters in cancer patients. Acta Haematol. 2001;106(1-2):69-72. doi: 10.1159/000046591.

  PMID: 11549779 BACKGROUND

• Elliott G. Upper-extremity deep vein thrombosis. Lancet. 1997 Apr 26;349(9060):1188-9. doi: 10.1016/S0140-6736(05)62408-7. No abstract available.

  PMID: 9130936 BACKGROUND

• 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. doi: 10.7326/0003-4819-136-12-200206180-00007.

  PMID: 12069560 BACKGROUND

• 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.

  PMID: 10494754 BACKGROUND

• 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. doi: 10.1159/000065215.

  PMID: 12372927 BACKGROUND

MeSH Terms

Conditions

Embolism and Thrombosis; Embolism; Thrombosis

Interventions

Dalteparin; Warfarin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michael J Kovacs, MD, FRCPC

  The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2002
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (6)