Trial from ANZCTR


Trial ID ACTRN12610000792022
Trial Status: Registered
Date Submitted: 16/09/2010
Date Registered: 24/09/2010
Retrospectively registered

Page 1

Public title Prevalence of Concurrent Deep Vein Thrombosis in Patients with Lower Limb Cellultis
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Prevalence of Concurrent Deep Vein Thrombosis in Patients with Lower Limb Cellultis
Update:
 
Reason:
 
Secondary ID [1] 252712 0
None
Update:
 
Reason:
 
UTN U1111-1111-0324
Update:
 
Reason:
 
Trial acronym N/A
Update:
 

Page 2

Health condition(s) or problem(s) studied:
Cellulitis of the lower limb 251938 0
 Update:
 Reason:
Deep vein thrombosis 251939 0
 Update:
 Reason:
Condition category: Condition code:
Infection Other infectious diseases
 Update:
 Update:
  Reason:
252121 252121 0 0
Blood Clotting disorders
 Update:
 Update:
  Reason:
252122 252122 0 0

Page 3

Descriptions of intervention(s) / exposure All patients with lower limb cellulitis will be investigated for concurrent deep venous thrombosis. This will be through application of the Wells score, which is a clinical assessment tool for assessing the probability of deep vein thrombosis, a D-dimer blood test and if neccessary an ultrasound scan of the deep venous system. This will occur once at recruitment.
Update:
 
Reason:
 
Intervention Code:
Diagnosis 241357 0
Update:
 
Reason:
 
Comparator / control treatment nil.
Update:
 
Reason:
 
Control group Uncontrolled
Update:
 
Reason:
 

Page 4

Primary Outcome: Prevalence of concurrent deep venous thrombosis in patients with cellulitis of the lower limb 253002 0
Update:
 
Reason:
 
Timepoint: At time of diagnosis 253002 0
Update:
 
Reason:
 
Secondary Outcome: Predictive value of the Wells score in this population. The Wells score is a clinical assessment tool for assessing the probability of deep vein thrombosis. 257774 0
Update:
 
Reason:
 
Timepoint: At time of diagnosis 257774 0
Update:
 
Reason:
 

Page 5

Key inclusion criteria Patients admitted to Christchurch Hospital with lower limb cellulitis
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
Key exclusion criteria nil
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Diagnosis
Update:
 
Allocation to intervention Nonrandomised trial
Update:
 
Reason:
 
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) All patients admitted with lower limb cellulitis will be approached by a member of the clinical team.
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) N/A
Update:
 
Reason:
 
Masking / blinding Open (masking not used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Single group
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/07/2010
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 200
Update:
 
Reason:
 
Recruitment status Closed: follow-up complete
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Country: New Zealand 2161 0
Update:
 
Reason:
 
State/Province: Canterbury 2161 0
Update:
 
Reason:
 

Page 8

Funding Source: Hospital 243818 0
Update:
 
Reason:
 
Name: Canterbury District Health Board 243818 0
Update:
 
Reason:
 
Address: Christchurch Hospital
Riccarton Ave
Private Bag 4710
Christchurch
8011
243818 0
Update:
 
Reason:
 
Country: New Zealand 243818 0
Update:
 
Reason:
 
Primary Sponsor Hospital
Update:
 
Reason:
 
Name: Canterbury District Health Board
Update:
 
Reason:
 
Address: Christchurch Hospital
Riccarton Ave
Private Bag 4710
Christchurch
8011
Update:
 
Reason:
 
Country: New Zealand
Update:
 
Reason:
 
Secondary Sponsor: None 237167 0
Update:
 
Reason:
 
Name: 237167 0
Update:
 
Reason:
 
Address: 237167 0
Update:
 
Reason:
 
Country: 237167 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: Upper South Regional Ethics Committee (NZ) 243947 0
Update:
 
Reason:
 
Address: C/- Ministry of Health
4th floor
250 Oxford Terrace
PO Box 3877
Christchurch
8011
243947 0
Update:
 
Reason:
 
Country: New Zealand 243947 0
Update:
 
Reason:
 
Approval Date: 243947 0
Update:
 
Reason:
 
Submitted Date: 01/10/2009 243947 0
Update:
 
Reason:
 
HREC: N/A 243947 0
Update:
 
Reason:
 
Brief summary Both lower limb cellulitis and deep vein thrombosis are common conditions that share some clinical features. This often leads to the investigation of possible deep vein thrombosis in patients with cellulitis. The result of a retrospective audit suggested that the rate of deep vein thrombosis in patients is low. This study would assess in a prospective way, the rate of deep venous thrombosis in patients with cellulitis. It would also assess the specificity of the currently used assessment criteria for possible deep vein thrombosis in patients with cellulitis.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
30341 0
Name:
Update:
 
Reason:
 
30341 0
Address:
Update:
 
Reason:
 
30341 0
Country:
Update:
 
30341 0
Reason:
 
Tel:
Update:
 
Reason:
 
30341 0
Fax:
Update:
 
Reason:
 
30341 0
Email:
Update:
 
Reason:
 
30341 0
Contact person for public queries
Title:
Update:
 
Reason:
 
13588 0
Name: Michael Maze
Update:
 
Reason:
 
13588 0
Address: Dept. Infectious Diseases Christchurch Hospital Riccarton Ave Private Bag 4710 Christchurch 8011
Update:
 
Reason:
 
13588 0
Country: New Zealand
Update:
 
13588 0
Reason:
 
Tel: +64 3 3640640
Update:
 
Reason:
 
13588 0
Fax:
Update:
 
Reason:
 
13588 0
Email: Michael.Maze@cdhb.govt.nz
Update:
 
Reason:
 
13588 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
4516 0
Name: Michael Maze
Update:
 
Reason:
 
4516 0
Address: Dept. Infectious Diseases Christchurch Hospital Riccarton Ave Private Bag 4710 Christchurch 8011
Update:
 
Reason:
 
4516 0
Country: New Zealand
Update:
 
4516 0
Reason:
 
Tel: +64 3 3640951
Update:
 
Reason:
 
4516 0
Fax: +64 3 3640952
Update:
 
Reason:
 
4516 0
Email: Michael.Maze@cdhb.govt.nz
Update:
 
Reason:
 
4516 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
22660 0
Name: Michael Maze
Update:
 
Reason:
 
22660 0
Address: Dept. Infectious Diseases Christchurch Hospital Riccarton Ave Private Bag 4710 Christchurch 8011
Update:
 
Reason:
 
22660 0
Country: New Zealand
Update:
 
22660 0
Reason:
 
Tel: +64 3 3640640
Update:
 
Reason:
 
22660 0
Fax:
Update:
 
Reason:
 
22660 0
Email: Michael.Maze@cdhb.govt.nz
Update:
 
Reason:
 
22660 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: