Treatment for Postthrombotic Syndrome

Phase-Based Estimates
2
Effectiveness
3
Safety
Sir Mortimer B. Davis - Jewish General Hospital, Montreal, Canada
Postthrombotic Syndrome+3 More
Eligibility
18+
All Sexes
Eligible conditions
Postthrombotic Syndrome

Study Summary

This study is evaluating whether a supplement might improve symptoms of the post-thrombotic syndrome.

See full description

Eligible Conditions

  • Postthrombotic Syndrome
  • Postphlebitic Ulcer
  • Syndrome
  • Postphlebitic Syndrome
  • Post Thrombotic Syndrome

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 19 secondary outcomes in patients with Postthrombotic Syndrome. Measurement will happen over the course of 9 months.

3 and 6 months
Patient compliance with treatment
Patients' overall satisfaction with treatment
3 and 9 months
Change in PTS
Month 9
General Quality of life
Venous specific Quality of life
3, 6, 9 months
Cramps
Heaviness
Hyperpigmentation
Pain
Paresthesia
Pre-tibial edema
Pruritus
Redness
Skin induration
Venous Ulcer
Venous ectasia
Villalta score
9 months
Serious Adverse Events (SAE)
Month 9
Severity of PTS

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Venixxa
Placebo group

This trial requires 86 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Venixxa
Drug
Micronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months
Placebo
Drug
Placebo for 6 months 1 Tablet, BID (morning and evening) for 6 months

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 9 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3, 6, 9 months for reporting.

Who is running the study

Principal Investigator
D. S. K.
Prof. Dr. Susan Kahn, MD
Sir Mortimer B. Davis - Jewish General Hospital

Closest Location

Sir Mortimer B. Davis - Jewish General Hospital - Montreal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Villalta score >4 with at least two of the following four PTS manifestations (daily heaviness, cramps, pain, and objective edema) in the leg ipsilateral to a previous objectively diagnosed DVT, or DVT of unknown date but with presence of residual proximal or distal venous obstruction on ultrasound

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can postthrombotic syndrome be?

Add answer

Symptoms of PTS and a predisposition to arterial embolism can lead to an arterial thrombosis in the upper limb in patients at an increased risk of a thrombotic event. The risk of subsequent arterial events including TE in patients with PTS is very low. When embolisms and/or arterial thromboses occur, they must be treated medically.

Unverified Answer

What are common treatments for postthrombotic syndrome?

Add answer

Current clinical management of postthrombotic syndrome differs substantially between countries. This is an important insight for future treatment of the condition and may guide the development of treatment guidelines. Furthermore, the development of new treatment modalities may broaden the options for patients with PTS.

Unverified Answer

How many people get postthrombotic syndrome a year in the United States?

Add answer

Postthrombotic syndrome affects approximately 1 in 2500 hospitalized patients. The incidence of postthrombotic syndrome is higher in women with an incidence of approximately 1% a year. The average length of stay is 9 days plus or minus 5 days. The number of complications with postthrombotic syndrome varies widely between patients.

Unverified Answer

What causes postthrombotic syndrome?

Add answer

We suggest that two factors, particularly an acute hypercoagulable state and a chronic thromboresis, are important factors for PTS. These factors seem to be associated with PTS.

Unverified Answer

What are the signs of postthrombotic syndrome?

Add answer

Symptoms of postthrombotic syndrome are not always present in the initial days after an inferior venous thromboembolism. Only when symptoms are present do patients have a low probability of having underlying venous thromboembolism and may benefit from anticoagulation on their own.

Unverified Answer

Can postthrombotic syndrome be cured?

Add answer

The authors concluded that postthrombotic syndrome most commonly resolves spontaneously in a period of weeks to months and that some patients have persistent improvement for up to 4 decades. There was a trend toward a more favorable clinical result for patients with low initial symptoms or no symptoms.

Unverified Answer

What is postthrombotic syndrome?

Add answer

PTPS, defined as chronic edema associated with new vascular lesions after deep vein thrombosis, occurs in about 8% of patients with DVT and usually resolves, with minimal treatment.

Unverified Answer

What are the latest developments in treatment for therapeutic use?

Add answer

The [recent advances in treatment of DVT and PE (thromboembolism) have improved treatment outcomes dramatically in past decades. In conclusion, the use of warfarin in the first 12 weeks of therapeutic use to prevent postthrombotic syndrome (PTS) is highly recommended.

Unverified Answer

What is the primary cause of postthrombotic syndrome?

Add answer

Postthrombotic syndrome is a multifactorial disease and can be of either autoimmune or nonautoimmune origin. The most common identifiable cause was autoimmune and more commonly associated with HLA-B51. The exact pathogenesis of postthrombotic syndrome remains unknown, but the underlying pathophysiology of this syndrome is associated with various factors such as an increased propensity for thrombosis, dysregulation of fibrinolysis and complement/immune system pathways, and an altered vascular wall and endothelial function. A multi-faceted approach to postthrombotic syndrome treatment should be investigated, including prophylactic anticoagulation and use of anti-inflammatory agents.

Unverified Answer

What are the common side effects of treatment?

Add answer

The most common side effects related to thrombectomy and antithrombotic therapy were [skin bruising or bleeding (4%), hematoma (3%), pain (3%), and swelling (3%)]. In a recent study, findings do not indicate a need to adjust thrombectomy and antithrombotic therapy on the basis of side effects.

Unverified Answer

Has treatment proven to be more effective than a placebo?

Add answer

Recent findings confirms that most of the treatments used for PTS are effective. However, because of the low quality of these trials their effectiveness should be viewed with skepticism. Given that this is a chronic low-pain disease, the effects of some treatments for PTS are difficult to judge. In particular, the benefits of physical exercise and the use of analgesics remain elusive.

Unverified Answer

Is treatment safe for people?

Add answer

A trial of low-dose aspirin and oral hydroxyzine showed a low absolute risk and safety on a high adverse event rate. Recent findings suggests that, in the presence of low bleeding risk and few adverse events, nonsteroidal anti-inflammatory drugs and NSAIDs are effective and safe therapies for thrombosis prophylaxis.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Postthrombotic Syndrome by sharing your contact details with the study coordinator.