Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients

Cancer Patients Clinical Trial

Official title:

A Pilot Study in Cancer Patients With Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in the Upper Extremity Treated With Low Molecular Weight Heparin (LMWH) and Apixaban (Catheter 3)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100071
• Other study ID #: R-17-160
• Status: Recruiting
• Start date: May 15, 2017
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: Lawson Health Research Institute
• Contact: Judy Kovacs, RN
• Phone: 519-685-8500
• Email: judy.kovacs[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.

Description:

Cancer patients who have developed blood clot in the arm that has the central venous catheter will be treated with standard of care blood thinning injection of low molecular weight heparin for 1 week and then for apixaban 5 mg twice daily for the rest of 11 weeks. Data will be collected to see if the central venous catheter "survived" or remained in place and did not have to be taken out because of the clot.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female > 18 years of age.

2. Symptomatic acute upper limb thrombosis in the axillary, subclavian or internal jugular veins, with or without pulmonary embolism, associated with central venous catheter objectively documented by compression ultrasonography, venogram or Computerized Tomography (CT) scan.

3. 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.

4. Willing to provide written informed consent.

Exclusion Criteria:

1. Presence of dialysis catheters

2. Active bleeding or high risk for major bleeding

3. Platelet Count < 75 x 109/L

4. Creatinine Clearance < 30 mL/min

5. Currently on other anticoagulant with therapeutic intent for another indication

6. Pulmonary embolism accompanied by hemodynamic instability or oxygen requirement

7. Inability to infuse through the catheter after a trial of intraluminal thrombolytic therapy (2 mg tPA).

8. Patients with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) or multiple myeloma with a bone marrow or stem cell transplant planned within the next 3 months

9. Treatment for current episode > 7 days with any acceptable anticoagulant therapy

10. Concomitant use of p-glucoprotein and Cytochrome P450 3A4 (CYP3A4) inhibitors (for example azole antifungals such as ketoconazole) or inducers (for example rifampicin, antiepileptics)

11. Recent coronary artery stent requiring dual anti-platelet therapy (for example acetylsalicylic acid [ASA] and Plavix)

12. If female of childbearing potential: pregnancy and/or breastfeeding

Related Conditions & MeSH terms

• Cancer Patients
• Central Venous Catheter Thrombosis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Upper Extremity Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban
Patients will be treated with Low Molecular Weight Heparin (LMWH) for 1 week and then with apixaban 5 milligram (mg) twice daily for 11 weeks.

Locations

Country	Name	City	State
Canada	London Health Science Center, Victoria Hospital	London	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Michael Kovacs	Jewish General Hospital, Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Line Failure	Infusion failure that does not respond to 2 milligram (mg) tissue Plasminogen Activator (tPA)	within 3 months of study follow-up
Secondary	Recurrent Venous Thromboembolism (VTE)	recurrence of blood clot either in leg or lung or both	within 3 months of study follow-up
Secondary	Bleeding	Major bleeding, clinically relevant minor bleed, death, time to central line failure	within 3 months of study follow-up