Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer (DVT)
Primary Purpose
Childhood Cancer, Central Venous Catheters, Deep Vein Thrombosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Cancer focused on measuring Childhood Cancer, Central Venous Catheter, Deep Vein Thrombosis, Catheter-related Infection, Catheter-related Occlusion
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of cancer
- Age ≤ 18 years
- First tunneled central venous catheter (implanted port or external) inserted in the upper venous system (subclavian, brachiocephalic, or jugular vein) within the previous 2 weeks
- Catheter expected to be in place for duration of chemotherapy (≥ 3 months)
- History of no more than one catheter complication (occlusion or infection)
Exclusion Criteria:
- Prior history of DVT
- Currently receiving an anticoagulant or anti-platelet agents on a daily basis
- Diagnosis of high grade malignant brain tumor or metastasis to the brain
- Clinical signs/symptoms of DVT
- Clinical signs/symptoms of Pulmonary embolism
- Renal failure
- Recent major hemorrhage
Sites / Locations
- Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A-randomized to treatment
B-randomized to close
Arm Description
Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks
Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks
Outcomes
Primary Outcome Measures
Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia
catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia
Secondary Outcome Measures
Bleeding Complications Associated With Enoxaparin Therapy, Need for Additional Platelets
Bleeding complications associated with enoxaparin therapy, need for additional platelets
Full Information
NCT ID
NCT00633061
First Posted
February 24, 2008
Last Updated
September 14, 2020
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00633061
Brief Title
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Acronym
DVT
Official Title
Phase II Study on the Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Futility; unable to complete screening due to clinical practice change
Study Start Date
June 2008 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary hypothesis of this study is that occult catheter-related DVT in children with cancer is common and directly contributes to development of serious catheter complications, specifically bacteremia/fungemia and/or recurrent occlusion of the catheter tip. Accordingly, anticoagulant treatment of clinically silent (occult) DVT will reduce rates of catheter-related infection and occlusion, delays in therapy and need for catheter replacement.
Detailed Description
This is a two-part study with an initial diagnosis component followed by a treatment component. The number of subjects to be consented for the diagnosis component is 350, and 50 for the treatment portion (25 on the observation arm, and 25 for enoxaparin treatment).
Study Procedures:
Patients diagnosed with cancer at the Center for Cancer and Blood Disorders will have a catheter inserted for cancer related treatment. After insertion, eligible patients who provide consent will be enrolled in the diagnosis component of the study. The principal investigator and research team will monitor for catheter complications (occlusion and bacteremia/fungemia). After two complications, participants will be screened for occult central venous catheter (CVC)-related DVT by contrast venography, ultrasonography, or magnetic resonance venography. If DVT is not diagnosed, participant will go off the study. If DVT is diagnosed, participant will be asked to consent to enroll in the treatment study. After enrollment, participant is randomized between the two arms of observation and enoxaparin treatment. After 6 weeks, patients will have another image; this represents the end of treatment period. After the follow-up imaging, patients will be monitored for 10 weeks to obtain primary outcomes. Once a primary outcome (progression to symptomatic DVT or pulmonary embolism (PE), blood stream infection or catheter removal) is achieved the participants can be treated with anticoagulation again if necessary, but primary oncologist will determine treatment.
Analysis:
The hypothesis is that the enoxaparin treatment group will have a median adverse catheter event free survival time of 12 weeks versus 4 weeks for the control group with a hazard ration of 0.4. A total sample size of 50 (25 in each arm) will detect such a difference with 90% power at an α=0.05. If there is a drop out rate of 10% in each arm, a difference can still be detected with 80% power.
Approximately 200 to 250 patients are diagnosed with cancer each year at Children's Medical Center Dallas, and based on prior institutional experience, two-thirds will have catheters inserted to facilitate chemotherapy. However, one-quarter of these patients have brain tumors and are not eligible due to the potential increased risk of intracranial hemorrhage with anticoagulation. There will be 100 patients each year who are at risk for CVC-related DVT. Based on previous studies, up to 50% of patients should develop occult DVT; however, only 35% of patients will likely be screened with radiographic imaging. Approximately 17 patients a year enrolled in the diagnosis study may be diagnosed with DVT and eligible for randomization. Therefore, total enrollment will be completed in approximately 3 years with an additional 4 months necessary to complete the follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer, Central Venous Catheters, Deep Vein Thrombosis, Catheter-related Infection, Catheter-related Occlusion
Keywords
Childhood Cancer, Central Venous Catheter, Deep Vein Thrombosis, Catheter-related Infection, Catheter-related Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-randomized to treatment
Arm Type
Experimental
Arm Description
Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks
Arm Title
B-randomized to close
Arm Type
No Intervention
Arm Description
Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Lovenox
Intervention Description
Lovenox ® is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. It is given as a subcutaneous injection twice daily. Dose of enoxaparin (Lovenox ®) will be 1 mg/kg every 12 hours for children >2 months and 1.5 mg/kg every 12 hours for infants <2 months. Duration of treatment is 6 weeks.
Primary Outcome Measure Information:
Title
Composite Endpoint for Arm B of the Study: Catheter Removal, Signs and Symptoms of DVT or PE, OR Bacteremia/Fungemia
Description
catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Bleeding Complications Associated With Enoxaparin Therapy, Need for Additional Platelets
Description
Bleeding complications associated with enoxaparin therapy, need for additional platelets
Time Frame
6 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cancer
Age ≤ 18 years
First tunneled central venous catheter (implanted port or external) inserted in the upper venous system (subclavian, brachiocephalic, or jugular vein) within the previous 2 weeks
Catheter expected to be in place for duration of chemotherapy (≥ 3 months)
History of no more than one catheter complication (occlusion or infection)
Exclusion Criteria:
Prior history of DVT
Currently receiving an anticoagulant or anti-platelet agents on a daily basis
Diagnosis of high grade malignant brain tumor or metastasis to the brain
Clinical signs/symptoms of DVT
Clinical signs/symptoms of Pulmonary embolism
Renal failure
Recent major hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janna Journeycake, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer
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