Clinical trial · Interventional
The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Embolism and Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalteparin | Drug | — | UNRESOLVED |
| Warfarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
Secondary outcomes (1)
- measure
- The secondary endpoints include recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE), major bleeding and death, time to central line failure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDKommareddy 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
- BACKGROUNDKooij 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
- BACKGROUNDMonreal 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
- BACKGROUNDVolturo 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
- BACKGROUNDMonreal 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
- BACKGROUNDElliott 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
- BACKGROUNDBaarslag 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
- BACKGROUNDSavage 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.