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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Monash Medical Centre.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Venous Thrombosis
Pulmonary Embolism
Drug: Enoxaparin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)

Resource links provided by NLM:


Further study details as provided by Monash Medical Centre:

Primary Outcome Measures:
  • Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 330
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Enoxaparin
    1.5mg/kg daily for 2 weeks
    Other Name: Clexane
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252420

Locations
Australia, New South Wales
Prince of Wales Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2031
Contact: Tim Brighton, MBBs, MD    +61293829013    Tim.Brighton@SESIAHS.HEALTH.NSW.GOV.AU   
Principal Investigator: Tim Brighton, MBBs, MD         
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Simon McRae, MBBs, BMedSci    +61 448882279      
Principal Investigator: Simon McRae, MBBs, BMedSci         
Australia, Victoria
Monash Medical Centre, Southern Health Recruiting
Melbourne, Victoria, Australia, 3168
Contact: Eileen Merriman, MBChB    +61 450011998    eileen.merriman@southernhealth.org.au   
Contact: Huyen Tran, MBBS, BClinEpi    +61 408780785    huyen.tran@southernhealth.org.au   
Principal Investigator: Huyen Tran, MBBs, MClinEp         
Sub-Investigator: Eileen Merriman, MBChB         
Sub-Investigator: Sanjeev Chunilal, MBChB         
New Zealand
Christchurch Hospital Not yet recruiting
Christchurch, Canterbury, New Zealand, 8011
Contact: Mark Smith, MBChB    +64 3 3640640    mark.smith@cdhb.govt.nz   
Principal Investigator: Mark Smith, MBChB         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Huyen Tran, MBBs(Hons), MClin Epidem Monash Medical Centre
  More Information

No publications provided

Responsible Party: Huyen Tran, Monash Medical Centre, Southern Health
ClinicalTrials.gov Identifier: NCT01252420     History of Changes
Other Study ID Numbers: DDVTANZ
Study First Received: July 20, 2010
Last Updated: December 3, 2010
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Keywords provided by Monash Medical Centre:
Distal Vein Thrombosis
Proximal Vein Thrombosis
Pulmonary Embolism
Post-thrombotic syndrome
Limited duration treatment

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Embolism
Pulmonary Embolism
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Vascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014