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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01252420




Registration number
NCT01252420
Ethics application status
Date submitted
20/07/2010
Date registered
3/12/2010
Date last updated
6/12/2010

Titles & IDs
Public title
Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis
Scientific title
Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)
Secondary ID [1] 0 0
DDVTANZ
Universal Trial Number (UTN)
Trial acronym
TWISTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin

Treatment: Drugs: Enoxaparin
1.5mg/kg daily for 2 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months.
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Asymptomatic proximal thrombus extension at 2 weeks
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Time course of symptom resolution and the proportion of patients with complete resolution at two weeks. - Time course of symptom resolution including time to complete resolution of symptoms, and the proportion of patients with complete resolution at two weeks.
Timepoint [2] 0 0
2 weeks
Secondary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Post-thrombotic syndrome
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Predictors of recurrent or progressive DVT or new PE
Timepoint [5] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre, Southern Health - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
Monash Medical Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Southern Health, Victoria
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Health, Victoria
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Adelaide Hospital, Adelaide
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Prince of Wales Hospital, Sydney
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Christchurch Hospital, NZ
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Auckland City Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
North Shore Hospital, New Zealand
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Middlemore Hospital, New Zealand
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01252420
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Huyen Tran, MBBs(Hons), MClin Epidem
Address 0 0
Monash Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01252420