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

NCT00216866

Last updated date
Study Location
Queen Elizabeth II Health Care Centre
Halifax, Nova Scotia, B3H 1Y8, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Embolism and Thrombosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Embolism and ThrombosisThe Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis
NCT00216866
  1. Halifax, Nova Scotia
  2. Hamilton, Ontario
  3. London, Ontario
  4. Ottawa, Ontario
  5. Ottawa, Ontario
  6. Montreal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis
Official Title  ICMJE 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
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.

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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Embolism and Thrombosis
Intervention  ICMJE
  • Drug: Dalteparin
  • Drug: Warfarin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 21, 2005)
70
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00216866
Other Study ID Numbers  ICMJE R-02-191
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Michael J Kovacs, MD, FRCPCUniversity of Western Ontario, Canada
PRS Account Lawson Health Research Institute
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP