The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis
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|ClinicalTrials.gov Identifier: NCT00216866|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Embolism and Thrombosis||Drug: Dalteparin Drug: Warfarin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 2002|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||March 2006|
- 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.
- The secondary endpoints include recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE), major bleeding and death, time to central line failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216866
|Canada, Nova Scotia|
|Queen Elizabeth II Health Care Centre|
|Halifax, Nova Scotia, Canada, B3H 1Y8|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 4G5|
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, KiY 4B1|
|Ottawa Civic Hospital|
|Ottawa, Ontario, Canada, KiY 4E9|
|Sir Mortimer B. Davis Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Principal Investigator:||Michael J Kovacs, MD, FRCPC||University of Western Ontario, Canada|