Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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.
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
Sex
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
NA
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
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2014
Actual
Sample size
Target
330
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
Government body
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
Government body
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01252420