Trial Outcomes & Findings for Management of Superficial Thrombophlebitis (NCT NCT00264381)
NCT ID: NCT00264381
Last Updated: 2013-11-18
Results Overview
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
Day 14
Results posted on
2013-11-18
Participant Flow
Consecutive patients, inpatient and outpatient, with ultrasound confirmed superficial thrombophlebitis of the upper or lower extremity
Exclusion criteria: receiving anticoagulant therapy for more than 24 hours, concurrent DVT, active bleeding, hypersensitivity to NSAIDS, pregnant or \<1 week post-partum, history of bleeding gastric ulcers, hemorrhagic CVA in last year, platelet count\<100K, bleeding disorder, serum creatine \> 2mg/dl, BP \> 180/110, weight \<40kg or \>135kg
Participant milestones
| Measure |
Ibuprofen 800 mg Tid
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Superficial Thrombophlebitis
Baseline characteristics by cohort
| Measure |
Ibuprofen 800 mg Tid
n=35 Participants
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 Participants
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52 years
n=5 Participants
|
51 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: Total number available for follow up
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Outcome measures
| Measure |
Ibuprofen 800 mg Tid
n=35 Participants
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 Participants
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Thrombosis Progression and Venous Thromboembolism (VTE)
Thrombosis progression
|
4 participants
|
0 participants
|
|
Thrombosis Progression and Venous Thromboembolism (VTE)
VTE
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Participants available for follow up
Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.
Outcome measures
| Measure |
Ibuprofen 800 mg Tid
n=35 Participants
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 Participants
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
Thrombosis progression
|
6 participants
|
4 participants
|
|
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
VTE
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 monthsNumber of participants with bleeding events related to treatment
Outcome measures
| Measure |
Ibuprofen 800 mg Tid
n=35 Participants
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 Participants
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1, Day 14Population: Participants available at follow up
Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain
Outcome measures
| Measure |
Ibuprofen 800 mg Tid
n=35 Participants
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 Participants
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Change From Baseline to Day 14 in Pain Assessment
|
-2.28 units on a scale
Standard Deviation 2.69
|
-2.23 units on a scale
Standard Deviation 2.01
|
Adverse Events
Ibuprofen 800 mg Tid
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dalteparin 200 U/kg Then 10,000 U Daily
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibuprofen 800 mg Tid
n=35 participants at risk
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 participants at risk
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Blood and lymphatic system disorders
Major bleeding
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
Other adverse events
| Measure |
Ibuprofen 800 mg Tid
n=35 participants at risk
Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days
\+ additional 7 days of same therapy based on result of ultrasound at day 7
|
Dalteparin 200 U/kg Then 10,000 U Daily
n=37 participants at risk
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
\+ additional 7 days of same therapy based on results of ultrasound at day 7
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • Number of events 1
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/35
|
5.4%
2/37 • Number of events 2
|
Additional Information
Suman Rathbun MD,MS
University of Oklahoma Health Sciences Center
Phone: 405271-4742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place