tinzaparin for Postthrombotic Syndrome

Phase-Based Estimates
3
Effectiveness
3
Safety
Juravinski Hospital and Cancer Centre, Hamilton, Canada
+6 More
tinzaparin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Postthrombotic Syndrome

Study Summary

This study is evaluating whether extended LMWH or DOAC is better for preventing PTS in patients with DVT.

See full description

Eligible Conditions

  • Postthrombotic Syndrome
  • Syndrome
  • Postphlebitic Ulcer
  • Venous Thrombosis
  • Thrombus
  • Post Thrombotic Syndrome
  • Postphlebitic Syndrome
  • Deep Vein Thrombosis
  • Thrombosis

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether tinzaparin will improve 2 primary outcomes, 9 secondary outcomes, and 1 other outcome in patients with Postthrombotic Syndrome. Measurement will happen over the course of 10 days post randomization.

10 days post randomization
Villalta score at 10 days
3 months post randomization
Main feasibility
6 months post randomization
Health Services Research Issues
PTS at 6 months
PTS severity
Rate of lost to follow-up
Month 6
QOL (Quality of Life) score - SF-36
QOL (Quality of Life) score - VEINES-QOL
Month 3
DVT-related leg pain
Global Improvement
Month 6
Patient's satisfaction with treatment
Month 6
SAEs

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Rivaroxaban
Tinzaparin

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tinzaparin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Tinzaparin
Drug
initial 3-week lead-in course of low molecular weight heparin (tinzaparin 175 units/Kg sc daily) followed by a direct oral anticoagulant (rivaroxaban 20mg po daily) for at least 3 months
Rivaroxaban
Drug
Direct oral anticoagulant only (rivaroxaban 15mg po BID for 3 weeks followed by rivaroxaban 20mg po daily ) for at least 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tinzaparin
FDA approved

Trial Logistics

Trial Timeline

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

Closest Location

Juravinski Hospital and Cancer Centre - Hamilton, 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:
1. Patients with objectively confirmed acute (i.e. onset of symptoms <10 days) symptomatic iliac or common femoral DVT (DVT diagnosis will be made with a Compression Ultrasound (CUS) according to standardized consensus criteria)

Patient Q&A Section

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

Can thrombus be cured?

Add answer

In our case the patient underwent thrombectomy in the right femoral artery without any complications. The thrombus was very small, and it would be impossible to cure the patient with this tool. Thus, we believe that thrombal aspiration should be only a complementary thrombectomy procedure in case of complete thrombectomy or when the lumen of the blood vessel is too narrow for the thrombus to pass through.

Unverified Answer

Who should consider clinical trials for thrombus?

Add answer

The American College of Chest Physicians and the American College of Cardiology recommend that all patients with acute ischemic stroke should be considered for clinical trials. [Published clinical trials at clinicaltrials.

Unverified Answer

How many people get thrombus a year in the United States?

Add answer

More than a year in a million US adolescents and adults have undergone surgery for nonfatal venous thromboembolism. More than 3.4 million, or about 1.4 per 10 000 population, had a venous thromboembolism diagnosed in the 12 months preceding the survey.

Unverified Answer

What is thrombus?

Add answer

Thrombus is the formation of a blood clot within a blood vessel. Blood clots can arise either from a break in the vessel wall (intraluminal thrombus) or within the lumen of a blood vessel (extraluminal thrombus). When blood clots develop in the coronary artery, they form, and they can form either within the artery supplying a tissue and thus within (intra-arterial thrombus) or outside (extra-arterial thrombus) the vessel.

Unverified Answer

What are the signs of thrombus?

Add answer

Signs of thrombosis should trigger high alertness for DVT. Abdominal pain is a new feature as a sign of DVT and was significantly related to a long latency to diagnosis. It was the most common symptom associated with thrombus. Although DVT is highly prevalent in patients with known risk factors, clinicians should be alert if any patients have new or increased signs/symptoms of DVT such as pain at the site of the clot, or fever.

Unverified Answer

What are common treatments for thrombus?

Add answer

Atherosclerotic plaque rupture and subsequent clot formation are the most common modes of embolization. While a variety of modalities and treatments are available, they are still limited by a paucity of evidence and a lack of consensus due to the complexity involved in the treatment of this disease.

Unverified Answer

What causes thrombus?

Add answer

Thrombus occurs because a clotting protein does not attach itself to a blood vessel wall. This happens when blood vessels are blocked by an embolus or other extrusion of substances. A clot is then formed and the vessel blocked by arterial thrombi. This can occur in the artery supplying the thigh or below the knee. The diagnosis is most likely to be correct when it is the result of a ruptured atheroma on an artery. In rare cases, the arterial blockage occurs in the vein. The diagnosis is typically made after a blockage develops in the thigh, calf or below the knee, and often the diagnosis is made during an examination of the leg.

Unverified Answer

Have there been other clinical trials involving tinzaparin?

Add answer

There are no studies involving tinzaparin for PE management, but studies do exist that mention tinzaparin in other, unrelated disorders. However, no other studies exist where tinzaparin has been studied as a single agent for PE or antifactor Xa in general. The absence of controlled studies on tinzaparin in PE and antifactor Xa in general is most likely because the results from clinical trials are often not published. Another possibility is that because a patient would be taking another therapeutic agent at a time when the study of tinzaparin is being performed, it would be difficult to know if the effects of tinzaparin were more profound compared with that of the other drug than they actually were.

Unverified Answer

What is the latest research for thrombus?

Add answer

For patients with a history of thromboembolic events, a balanced diet, weight stability, cessation of tobacco use, appropriate exercise, and anticoagulant therapy remain the standard of care. Although these modalities are effective, they are often inappropriate and costly, and have a number of limitations and complications. Further research is necessary to determine what treatment provides better outcomes or improves quality of life for these patients.

Unverified Answer

Is tinzaparin safe for people?

Add answer

Tinzaparin appears to be safe and may have a clinical benefit for patients with thrombin-induced thrombotic thrombocytopenia. A randomised clinical trial is required to further assess the efficacy and safety of tinzaparin after a major bleeding episode. A meta-analysis of three recent trials of tinzaparin showed no significant difference in bleeding or blood product transfusion between low-molecular-weight heparin and tinzaparin.

Unverified Answer

What are the latest developments in tinzaparin for therapeutic use?

Add answer

There is still insufficient evidence for the use of tinzaparin for preventing thromboembolic complications related to the post-thrombotic syndrome. Based on evidence from controlled studies with other anticoagulants, there is a good rationale for the use of tinzaparin in patients with symptomatic post-thrombotic syndrome, but there is no evidence for the efficacy of tinzaparin in an anticoagulant-uncontrolled postthrombotic syndrome cohort.

Unverified Answer

What are the common side effects of tinzaparin?

Add answer

Thrombocytopenia (>40×109 cells/L) and pain/burning at site of injection were the most frequent adverse events observed through post-marketing surveillance. Thrombocytopenia and pain/burning at site of injection were more common with tinzaparin than with the newer (non-peptide) thromboprophylaxis agents.

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.