NCT01252420

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 6, 2010

Status Verified

July 1, 2010

Enrollment Period

3 years

First QC Date

July 20, 2010

Last Update Submit

December 3, 2010

Conditions

Venous ThrombosisPulmonary Embolism

Keywords

Distal Vein ThrombosisProximal Vein ThrombosisPulmonary EmbolismPost-thrombotic syndromeLimited duration treatment

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (5)

  • Asymptomatic proximal thrombus extension at 2 weeks

    2 weeks

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

    2 weeks

  • All-cause mortality

    3 months

  • Post-thrombotic syndrome

    6 months

  • Predictors of recurrent or progressive DVT or new PE

    3 months

Interventions

EnoxaparinDRUG

1.5mg/kg daily for 2 weeks

Also known as: Clexane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

NOT YET RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

NOT YET RECRUITING

Monash Medical Centre, Southern Health

Melbourne, Victoria, 3168, Australia

RECRUITING

Christchurch Hospital

Christchurch, Canterbury, 8011, New Zealand

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 34530387DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismPostthrombotic Syndrome

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismVenous Insufficiency

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Huyen Tran, MBBs(Hons), MClin Epidem

    Monash Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2010

First Posted

December 3, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2014

Last Updated

December 6, 2010

Record last verified: 2010-07

Locations

AU(3)NZ(1)