Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216866
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2005-09-19
Brief Title:
The Catheter Study Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin Dalteparin for the Treatment of Deep Vein Thrombosis
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 01 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 standardizedTherapeutic 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
The therapy of UEDVT has not been standardizedTherapeutic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None