Trial Outcomes & Findings for Identification and Treatment of Clinically Silent Catheter-Related Deep Vein Thrombosis in Children With Cancer (NCT NCT00633061)

Results Overview

catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

16 weeks

Results posted on

2020-10-08

Participant Flow

Recruitment from June 2008 to December 2010. For arm A, we screened 486 children and enrolled 136. 68 patients were eligible and not enrolled and 282 were ineligible. No patient was eligible for Arm B of this study

Participant milestones

Participant milestones
Measure	A-Prosepctive Screening for Asymptomatic DVT Patients \</=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring tpa or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B	B-Randomized Clinical Trail for Treatment Patients diagnosed with asymptomatic catheter-related DVT who are randomized to between enoxaparin or close observation for 6 weeks
Overall Study STARTED	136	0
Overall Study Met Criteria for Imaging	25	0
Overall Study Had Prior Thrombosis Identified	25	0
Overall Study COMPLETED	50	0
Overall Study NOT COMPLETED	86	0

Reasons for withdrawal

Reasons for withdrawal
Measure	A-Prosepctive Screening for Asymptomatic DVT Patients \</=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring tpa or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B	B-Randomized Clinical Trail for Treatment Patients diagnosed with asymptomatic catheter-related DVT who are randomized to between enoxaparin or close observation for 6 weeks
Overall Study Study closed	86	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-Prosepctive Screeing for Asymptomatic DVT n=136 Participants Patients diagnosed with asymptomatic catheter-related DVT who are randomized to treatment with enoxaparin for 6 weeks 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.	B-Randomized Clinical Trail for Treatment Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation for 6 weeks	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	136 Participants n=93 Participants	—	136 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Continuous	10 years n=93 Participants	—	10 years n=27 Participants
Sex: Female, Male Female	69 Participants n=93 Participants	—	69 Participants n=27 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	—	67 Participants n=27 Participants
Region of Enrollment United States	136 participants n=93 Participants	—	136 participants n=27 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: No patient was enrolled on the randomized clinical trial (arm B) after being on the prospective screening trial (Arm A)

catheter removal, signs and symptoms of DVT or PE, OR bacteremia/fungemia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Since no patient was enrolled on Arm B of this study, there is no analysis of bleeding.

Bleeding complications associated with enoxaparin therapy, need for additional platelets

Outcome measures

Outcome data not reported

Adverse Events

A-Prospective Screening for Asymptomatic Catheter-related DVT

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

B-Randomized Clinical Trial

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A-Prospective Screening for Asymptomatic Catheter-related DVT n=136 participants at risk Patients \</=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring thrombolysis or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B	B-Randomized Clinical Trial Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation vs enoxaparin for 6 weeks
Vascular disorders Thrombosis	5.1% 7/136 • Number of events 7	— 0/0
Vascular disorders removal of indwelling catheter for reasons other than end of therapy	6.6% 9/136 • Number of events 9	— 0/0

Other adverse events

Adverse event data not reported

Additional Information

Janna Journeycake, MD

Univesity of Oklahoma College of Medicine

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place