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Venous ThrombosisPhase 4TWISTERNCT01252420

Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis

A Phase 4 study testing Enoxaparin in people with Venous Thrombosis and Pulmonary Embolism, run by Monash Medical Centre at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the lower limb. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thrombosis, Pulmonary Embolism
What is being tested?
Enoxaparin
How many people
330 participants
Where
4 sitesin 2 countries
Study dates
Nov 2010to Nov 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years or older with acute symptomatic provoked or unprovoked distal vein thrombosis (axial or muscular veins but not involving trifurcation or distal popliteal vein)
  • Absence of symptomatic pulmonary embolism

Who cannot join

  • DVT involving trifurcation or more proximal leg veins on imaging
  • Prior DVT
  • Active malignancy ie present at time of diagnosis, or on treatment, or treatment completed within 3 months
  • Ongoing risk factors for propagation e.g. immobility (>50% of day in bed or ≥72 hours), plaster cast or non-weight bearing
  • Other indication for therapeutic anticoagulation (e.g. AF)
  • Active gastro-oesophageal ulceration or bleeding
Show all 9Show fewer
  • Other high risk for bleeding (e.g. recent neurosurgery, vascular retinopathy, coagulopathy)
  • Platelet count <80 x 109/L
  • Renal impairment (CrCl <30ml/min) • Pregnancy or lactation

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Australia3 sites, 3 recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Simon McRae, MBBs, BMedSci, +61 448882279

    Simon McRae, MBBs, BMedSci

    Not yet recruiting

  • Monash Medical Centre, Southern Health

    Melbourne, Victoria, 3168

    Eileen Merriman, MBChB, +61 450011998, eileen.merriman@southernhealth.org.au

    Huyen Tran, MBBS, BClinEpi, +61 408780785, huyen.tran@southernhealth.org.au

    Recruiting

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

    Tim Brighton, MBBs, MD, +61293829013, Tim.Brighton@SESIAHS.HEALTH.NSW.GOV.AU

    Tim Brighton, MBBs, MD

    Not yet recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • Christchurch Hospital

    Christchurch, Canterbury, 8011

    Mark Smith, MBChB, +64 3 3640640, mark.smith@cdhb.govt.nz

    Mark Smith, MBChB

    Not yet recruiting

Other trials in New Zealand

About this study

Official title: Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)

The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the lower limb.

Read the detailed description

Approximately 50% of symptomatic episodes of deep vein thrombosis (DVT) will be confined to the calf veins (distal DVT). The proportion of distal DVT that propagate to the proximal veins, increasing the risk of pulmonary embolism, is not known. The best treatment of isolated distal DVT is therefore controversial and options include no treatment, follow-up scanning and treatment of only those patients with thrombus propagating to proximal veins, and full anticoagulation for periods ranging from 2 weeks to 3 months.

There is good evidence that the 3-month thromboembolic risk in patients with a negative CUS that is limited to the proximal veins is low, in the order of 1%. Previous studies have demonstrated that patients treated with a short period of anticoagulation (4-6 weeks) have a low risk of developing recurrent DVT or PE. In addition, the specificity of CUS for distal DVT is lower than that for proximal DVT, increasing the proportion of false positive findings, making it likely that a proportion of patients diagnosed with distal DVT are treated unnecessarily, with the attendant risks of major and fatal haemorrhage.

The need for anticoagulation of patients with distal DVT to prevent recurrent DVT is therefore uncertain, however a survey of current practice suggested that most patients with this condition currently receive antithrombotic therapy. The impact of anticoagulation on initial patient symptoms, and the subsequent risk of the post-thrombotic syndrome are also unclear, and may be a possible alternative justification for antithrombotic therapy.

In this proposed multicentre, prospective, cohort study, we plan to determine if a shorter duration of anticoagulation (minimum 2 weeks) is a safe and effective treatment for isolated distal vein thrombosis.

Being tested
Enoxaparin
Keywords
Distal Vein Thrombosis, Proximal Vein Thrombosis, Pulmonary Embolism, Post-thrombotic syndrome, Limited duration treatment
Medical subject headings
Venous Thrombosis, Pulmonary Embolism, Postthrombotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoxaparinDrug

    Also called Clexane

    1.5mg/kg daily for 2 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months.

    Measured: 3 months

Secondary outcomes (5)

  1. Asymptomatic proximal thrombus extension at 2 weeks

    Measured: 2 weeks

  2. Time course of symptom resolution and the proportion of patients with complete resolution at two weeks.

    Time course of symptom resolution including time to complete resolution of symptoms, and the proportion of patients with complete resolution at two weeks.

    Measured: 2 weeks

  3. All-cause mortality

    Measured: 3 months

  4. Post-thrombotic syndrome

    Measured: 6 months

  5. Predictors of recurrent or progressive DVT or new PE

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2013 (estimated)
  4. Study completionNov 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01252420
Sponsor's protocol ID
DDVTANZ
Acronym
TWISTER
Status last verified
Jul 2010
First submitted
20 Jul 2010
Last updated
6 Dec 2010
Results posted
No
Data monitoring committee
No

Publications

  • Merriman E, Chunilal S, Brighton T, Chen V, McRae S, Ockelford P, Curnow J, Tran H, Chong B, Smith M, Royle G, Crowther H, Slocombe A, Tran H. Two Weeks of Low Molecular Weight Heparin for Isolated Symptomatic Distal Vein Thrombosis (TWISTER study). Thromb Res. 2021 Nov;207:33-39. doi: 10.1016/j.thromres.2021.09.004. Epub 2021 Sep 11.

    PubMed 34530387

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enoxaparin in people with Venous Thrombosis and Pulmonary Embolism, run by Monash Medical Centre at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01252420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2010.

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