Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Venous Thrombosis Pulmonary Embolism||Drug: Enoxaparin||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2014|
- Drug: Enoxaparin
1.5mg/kg daily for 2 weeksOther Name: Clexane
- Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months. [ Time Frame: 3 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252420
|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|
|Monash Medical Centre, Southern Health||Recruiting|
|Melbourne, Victoria, Australia, 3168|
|Contact: Eileen Merriman, MBChB +61 450011998 firstname.lastname@example.org|
|Contact: Huyen Tran, MBBS, BClinEpi +61 408780785 email@example.com|
|Principal Investigator: Huyen Tran, MBBs, MClinEp|
|Sub-Investigator: Eileen Merriman, MBChB|
|Sub-Investigator: Sanjeev Chunilal, MBChB|
|Christchurch Hospital||Not yet recruiting|
|Christchurch, Canterbury, New Zealand, 8011|
|Contact: Mark Smith, MBChB +64 3 3640640 firstname.lastname@example.org|
|Principal Investigator: Mark Smith, MBChB|
|Principal Investigator:||Huyen Tran, MBBs(Hons), MClin Epidem||Monash Medical Centre|