Lower Extremity Superficial Thrombophlebitis, Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis
Conditions
Keywords
Superficial Thrombophlebitis, STP, Fragmin, Ibuprofen, Superficial Thrombus, Superficial Phlebitis, phlebitis
Brief summary
The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).
Detailed description
Superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. In the absence of treatment, STP may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism. Current standard therapy for STP consists of local heat, elevation of the extremity, and non-steroidal anti-inflammatory medication. However, no study to date has adequately evaluated the effectiveness of this therapy despite persistence and recurrence of symptoms of STP in many patients. The purpose of this study is to document the outcome of patients with objectively documented STP who are treated with NSAID therapy (standard care) verses those treated with low-molecular weight heparin (dalteparin sodium) according to a pre-defined treatment regimen. All patients with documented upper or lower STP will be screened. Each will have a complete baseline and risk factor assessment. All patients will be randomized in one of two treatment groups: (a) Experimental group who will receive Fragmin (dalteparin)fixed dose subcutaneously daily for 7 days or (b) Control group who will receive ibuprofen 800mg given orally three times daily for 7 days. All patients will receive study drug for a period of 1-2 weeks with reassessment of STP by ultrasound. All patients will participate for a period of 3 months with follow up visits at 7-9, and 14-16 day, and 1,3 months.
Interventions
Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.
Sponsors
Pfizer
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging
Exclusion criteria
* Active, clinically significant bleeding * Known hypersensitivity to NSAIDS, heparin or derivatives * Currently pregnant or \< 1 week post-partum * Acquired bleeding diathesis * Known inherited bleeding disorder * Renal failure * Extremes of weight * unable to return for repeat diagnostic testing or follow-up visit * Concurrent deep-vein thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis Progression and Venous Thromboembolism (VTE) | Day 14 | Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing |
| Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | 3 months | Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | 3 months | Number of participants with bleeding events related to treatment |
| Change From Baseline to Day 14 in Pain Assessment | Day 1, Day 14 | 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 |
Countries
United States
Participant flow
Recruitment details
Consecutive patients, inpatient and outpatient, with ultrasound confirmed superficial thrombophlebitis of the upper or lower extremity
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 37 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|---|
| Age Continuous | 51 years | 52 years | 51 years |
| Region of Enrollment United States | 72 participants | 35 participants | 37 participants |
| Sex: Female, Male Female | 51 Participants | 27 Participants | 24 Participants |
| Sex: Female, Male Male | 21 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 35 | 2 / 37 |
| serious Total, serious adverse events | 1 / 35 | 0 / 37 |
Outcome results
Primary
Thrombosis Progression and Venous Thromboembolism (VTE)
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Time frame: Day 14
Population: Total number available for follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibuprofen 800 mg Tid | Thrombosis Progression and Venous Thromboembolism (VTE) | Thrombosis progression | 4 participants |
| Ibuprofen 800 mg Tid | Thrombosis Progression and Venous Thromboembolism (VTE) | VTE | 0 participants |
| Dalteparin 200 U/kg Then 10,000 U Daily | Thrombosis Progression and Venous Thromboembolism (VTE) | Thrombosis progression | 0 participants |
| Dalteparin 200 U/kg Then 10,000 U Daily | Thrombosis Progression and Venous Thromboembolism (VTE) | VTE | 0 participants |
Primary
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.
Time frame: 3 months
Population: Participants available for follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibuprofen 800 mg Tid | Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | Thrombosis progression | 6 participants |
| Ibuprofen 800 mg Tid | Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | VTE | 0 participants |
| Dalteparin 200 U/kg Then 10,000 U Daily | Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | Thrombosis progression | 4 participants |
| Dalteparin 200 U/kg Then 10,000 U Daily | Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | VTE | 1 participants |
Secondary
Change From Baseline to Day 14 in Pain Assessment
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
Time frame: Day 1, Day 14
Population: Participants available at follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen 800 mg Tid | Change From Baseline to Day 14 in Pain Assessment | -2.28 units on a scale | Standard Deviation 2.69 |
| Dalteparin 200 U/kg Then 10,000 U Daily | Change From Baseline to Day 14 in Pain Assessment | -2.23 units on a scale | Standard Deviation 2.01 |
Secondary
Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.
Number of participants with bleeding events related to treatment
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibuprofen 800 mg Tid | Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | 0 participants |
| Dalteparin 200 U/kg Then 10,000 U Daily | Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | 0 participants |