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Trial record 17 of 56 for:    "Lung Disease" | "Dalteparin"

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

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ClinicalTrials.gov Identifier: NCT01252420
Recruitment Status : Unknown
Verified July 2010 by Monash Medical Centre.
Recruitment status was:  Recruiting
First Posted : December 3, 2010
Last Update Posted : December 6, 2010
Sponsor:
Collaborators:
Southern Health, Victoria
Eastern Health, Victoria
Royal Adelaide Hospital, Adelaide
Prince of Wales Hospital, Sydney
Christchurch Hospital, NZ
Auckland City Hospital
North Shore Hospital, New Zealand
Middlemore Hospital, New Zealand
Information provided by:
Monash Medical Centre

Tracking Information
First Submitted Date  ICMJE July 20, 2010
First Posted Date  ICMJE December 3, 2010
Last Update Posted Date December 6, 2010
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. [ Time Frame: 2 weeks and 3 months ]
Change History Complete list of historical versions of study NCT01252420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
  • Asymptomatic proximal thrombus extension at 2 weeks [ Time Frame: 2 weeks ]
  • Time course of symptom resolution and the proportion of patients with complete resolution at two weeks. [ Time Frame: 2 weeks ]
    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 ]
  • Post-thrombotic syndrome [ Time Frame: 6 months ]
  • Predictors of recurrent or progressive DVT or new PE [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis
Official Title  ICMJE Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Venous Thrombosis
  • Pulmonary Embolism
Intervention  ICMJE Drug: Enoxaparin
1.5mg/kg daily for 2 weeks
Other Name: Clexane
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 2, 2010)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01252420
Other Study ID Numbers  ICMJE DDVTANZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Huyen Tran, Monash Medical Centre, Southern Health
Study Sponsor  ICMJE Monash Medical Centre
Collaborators  ICMJE
  • Southern Health, Victoria
  • Eastern Health, Victoria
  • Royal Adelaide Hospital, Adelaide
  • Prince of Wales Hospital, Sydney
  • Christchurch Hospital, NZ
  • Auckland City Hospital
  • North Shore Hospital, New Zealand
  • Middlemore Hospital, New Zealand
Investigators  ICMJE
Principal Investigator: Huyen Tran, MBBs(Hons), MClin Epidem Monash Medical Centre
PRS Account Monash Medical Centre
Verification Date July 2010

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