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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

Phase 2
18 Years
Not Enrolling
Embolism and Thrombosis

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Trial Information

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

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 estimated to constitute 1-5% of all cases of DVT.

The therapy of UEDVT has not been standardized.Therapeutic options include anticoagulation
with unfractionated heparin followed by warfarin, treatment with a thrombolytic agent, or a
thrombectomy. Recently, treatment with low molecular weight heparin has been shown to be a
safe and effective treatment for patients with verified UEDVT.

In patients with cancer, treatment of UEDVT associated with central venous catheters is even
less standardized. Some groups advocate removal of the catheter as the sole treatment for
the DVT, others remove the catheter and treat the DVT. A major disadvantage to removing the
line is that often re-insertion in the opposite limb is then required to avoid disruption of
chemotherapeutic treatment. This reinsertion again puts the patient at risk for thrombosis
and pulmonary embolism. Another therapy is treatment only with systemic thrombolytic
therapy. The disadvantage of thrombolytic therapy in persons with cancer is that there is a
high risk for major bleeding at the doses used.

A treatment regimen that has been adopted by the London Health Sciences Centre, and others
across Canada, is to leave the catheter in place and treat the DVT with low molecular weight
heparin and warfarin. This regimen is believed to halt the progression of thrombi, prevent
embolism and allow natural thrombolytic mechanisms to work effectively. By leaving the
central line in situ and appropriately treating the thrombosis there is no disruption in the
delivery of life-prolonging or life-saving treatment in the form of chemotherapy.

Preliminary data has been collected over the past 24 months at the London Health Sciences
Centre; the results suggest that this approach to treatment will prove to be beneficial to
the patient. Thirteen (13) patients with cancer and an UEDVT associated with a central
venous catheter were treated with dalteparin and warfarin with an intention to leave the
central line in situ. Of the 13, 1 patient had the line removed after 3 days at a peripheral
hospital against recommendation. The UEDVT was treated successfully and without the need for
line removal in 9 (75%) of the remaining 12 patients. Two (2) of the 12 had lines removed at
1 week and 1 had the line removed at 4 weeks due to worsening symptoms of UEDVT.

Therefore, UEDVT is a more common and less benign disease than previously reported and
generally arises in the presence of recognizable risk factors such as central venous
catheters and cancer. Treatment of the UEDVT with dalteparin and warfarin will treat the
thrombosis while preserving the central venous access for continued use. Hence, the need for
additional catheters and subsequent risk of bilateral UEDVT will be minimized.

Result of the CLOT (Clot in Cancer) Trial have shown the superiority of treatment with
dalteparin for 6 months as compared to the conventional treatment with short-term dalteparin
and extended warfarin for cancer patients with acute symptomatic DVT or PE. Extended
anticoagulant therapy may be beneficial in patients with UEDVT as well, however, there are
currently no estimates of clinical outcomes for either conventional (dalteparin followed by
warfarin) or extended therapy with dalteparin in this patient population.

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

- Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)
with a bone marrow or stem cell transplant pending in next 3 months.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Michael J Kovacs, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Western Ontario, Canada


Canada: Health Canada

Study ID:




Start Date:

September 2002

Completion Date:

March 2006

Related Keywords:

  • Embolism and Thrombosis
  • Embolism
  • Thrombosis
  • Embolism
  • Thrombosis
  • Venous Thrombosis
  • Embolism and Thrombosis