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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00633061 |
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.
Condition | Intervention | Phase |
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Childhood Cancer Central Venous Catheters Deep Vein Thrombosis Catheter-Related Infection Catheter-Related Occlusion |
Drug: Enoxaparin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study on the Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer |
Estimated Enrollment: | 300 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks
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Drug: Enoxaparin
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.
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B: No Intervention
Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks
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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 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/ 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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Janna Journeycake, MD | 214-456-8556 | Janna.Journeycake@childrens.com |
Contact: Roberto Torres, MA | 214-456-6095 | Roberto.Torres@childrens.com |
United States, Texas | |
Children's Medical Center | Recruiting |
Dallas, Texas, United States, 75235 | |
Contact: Janna Journeycake, MD 214-456-8556 Janna.Journeycake@childrens.com | |
Contact: Roberto Torres, MA 214-456-6095 Roberto.Torres@childrens.com | |
Principal Investigator: Janna Journeycake, MD |
Principal Investigator: | Janna Journeycake, MD | University of Texas Southwestern |
Responsible Party: | University of Texas Southwestern Medical Center Dallas ( Janna Journeycake, MD ) |
Study ID Numbers: | K23 HL084097, IRB # 122007-062 |
Study First Received: | February 24, 2008 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00633061 History of Changes |
Health Authority: | United States: Institutional Review Board |
Childhood Cancer Central Venous Catheter Deep Vein Thrombosis Catheter-related Infection Catheter-related Occlusion |
Anticoagulants Heparin, Low-Molecular-Weight Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thrombosis Calcium heparin |
Enoxaparin Embolism and Thrombosis Fibrin Modulating Agents Embolism Venous Thrombosis Heparin |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Infection Thrombosis |
Pharmacologic Actions Enoxaparin Embolism and Thrombosis Fibrin Modulating Agents Therapeutic Uses Venous Thrombosis Cardiovascular Diseases |