Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer

NCT00633061 | Terminated Phase 2 Results DMC

• 2 other identifiers: K23HL084097STU12207-062
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  16 weeks

Secondary Outcomes (1)

• Bleeding Complications Associated With Enoxaparin Therapy, Need for Additional Platelets

  6 weeks

Study Arms (2)

A-randomized to treatment

EXPERIMENTAL

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks

Drug: Enoxaparin

B-randomized to close

NO INTERVENTION

Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks

Interventions

Enoxaparin DRUG

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.

Also known as: Lovenox

A-randomized to treatment

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Neoplasms; Venous Thrombosis; Catheter-Related Infections

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Infections

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Study terminated early for lack of accrual on Arm B (randomized trial). No patient enrolled on Arm A (screening study) were eligible. Standard treatment of asymptomatic catheter-related DVT changed in 2010, favoring treatment with enoxaparin.

Results Point of Contact

• Title: Janna Journeycake, MD
• Organization: Univesity of Oklahoma College of Medicine

janna-journeycake@ouhsc.edu

Study Officials

• Janna Journeycake, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 11, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 8, 2020
• Results First Posted: March 8, 2019

Record last verified: 2020-09

Locations

US (1)