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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2010 by Monash Medical Centre
Sponsor:
Collaborators:
Southern Health, Victoria
Eastern Health, Victoria
Royal Adelaide Hospital, Adelaide
Prince of Wales Hospital, Sydney
Christchurch Hospital, NZ
Auckland City Hospital, New Zealand
North Shore Hospital, New Zealand
Middlemore Hospital, New Zealand
Information provided by:
Monash Medical Centre
ClinicalTrials.gov Identifier:
NCT01252420
First received: July 20, 2010
Last updated: December 3, 2010
Last verified: July 2010

July 20, 2010
December 3, 2010
November 2010
November 2013   (final data collection date for primary outcome measure)
Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. [ Time Frame: 2 weeks and 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01252420 on ClinicalTrials.gov Archive Site
  • Asymptomatic proximal thrombus extension at 2 weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Time course of symptom resolution and the proportion of patients with complete resolution at two weeks. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Time course of symptom resolution including time to complete resolution of symptoms, and the proportion of patients with complete resolution at two weeks.
  • All-cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Post-thrombotic syndrome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Predictors of recurrent or progressive DVT or new PE [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis
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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Thrombosis
  • Pulmonary Embolism
Drug: Enoxaparin
1.5mg/kg daily for 2 weeks
Other Name: Clexane
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
November 2014
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
New Zealand,   Australia
 
NCT01252420
DDVTANZ
No
Huyen Tran, Monash Medical Centre, Southern Health
Monash Medical Centre
  • Southern Health, Victoria
  • Eastern Health, Victoria
  • Royal Adelaide Hospital, Adelaide
  • Prince of Wales Hospital, Sydney
  • Christchurch Hospital, NZ
  • Auckland City Hospital, New Zealand
  • North Shore Hospital, New Zealand
  • Middlemore Hospital, New Zealand
Principal Investigator: Huyen Tran, MBBs(Hons), MClin Epidem Monash Medical Centre
Monash Medical Centre
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP