Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000501640
Ethics application status
Not yet submitted
Date submitted
3/05/2014
Date registered
12/05/2014
Date last updated
12/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Number of clots found in the arms of high risk surgical patients with a drip
Scientific title
Incidence of upper limb deep vein thrombosis in high risk surgical patients with cannulas
Secondary ID [1] 284534 0
Nil
Universal Trial Number (UTN)
U1111-1156-3365
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb deep vein thrombosis 291796 0
Condition category
Condition code
Surgery 292159 292159 0 0
Other surgery
Cardiovascular 292217 292217 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
We will enrol patients into the study. At enrolment the patient will have an ultrasound to see if they have a deep vein thrombosis (DVT). If they have a DVT they will be excluded from the study. They will have a second ultrasound at discharge to look for an upper limb DVT. If a patient is found to have an upper limb DVT, they will be treated with the standard DVT protocol.
Intervention code [1] 289298 0
Not applicable
Comparator / control treatment
No control is used
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292039 0
To determine the incidence of upper limb DVTs in high risk surgical patients with cannulas in the dorsal hand/forearm. This will be assessed using ultrasound.
Timepoint [1] 292039 0
30 days after enrolment
Secondary outcome [1] 308060 0
To identify upper limb DVTs in high risk surgical patients with cannulas. This will be assessed using ultrasound.
Timepoint [1] 308060 0
30 days after enrolment

Eligibility
Key inclusion criteria
- 65 years or older
-a cannula in forearm/dorsum of the hand, inserted on admission
-FBC and INR performed on admission
-Patients with one or more of the following criteria:
-underlying malignancy ,
-thrombophilias (Factor C deficiency, Factor S deficiency, Factor 5 Leiden mutation, Anti thrombin 3 deficiency, anti-phospholipid syndrome, Prothrombin 20210A mutation)
-previous surgery or trauma
A high risk surgical patient will be classified as a patient with two or more risk factors (one of the risk factors will be aged over 65).
Minimum age
65 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-previous or current trauma of upper limb or chest
-previous or current upper limb, neck or axillary surgery
-previous or current upper limb DVT
-previous mastectomy
-thoracic outlet syndrome
-enlarged lymph nodes/tumours causing upper limb venous compression

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The sample size estimates were based on the results of previous studies conducted on the prevalence of upper limb DVT in patients with malignancy who received central lines and PICC lines. We estimated that the expected prevalence of DVT is 20%. Using the sample size calculation, it was estimated that for a 95% confidence interval of 15-25% a sample size of 246 participants was required. For 95% CI of 10-30% a sample size of 62 participants will be our aim.

Data analysis will be performed using SPSS. Descriptive statistics will be generated. Parametric data will be expressed as means +/- standard deviations while the non-parametric data will be expressed as medians and quartile ranges.
Dichotomous variables will be analysed using the chi squared test. Dichotomous versus continuous variables will be analysed using the t tests if the data is parametric, and Mann-Whitney if the data is non parametric.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2399 0
Mackay Base Hospital - Mackay

Funding & Sponsors
Funding source category [1] 289166 0
University
Name [1] 289166 0
James Cook University
Country [1] 289166 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Dr, Townsville City QLD 4811
Country
Australia
Secondary sponsor category [1] 287835 0
None
Name [1] 287835 0
Address [1] 287835 0
Country [1] 287835 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290940 0
Townsville Hospital and Health Service
Ethics committee address [1] 290940 0
HREC Administrator
The Townsville Hospital
IMB 48, PO Box 670
Townsville QLD 4810
Ethics committee country [1] 290940 0
Australia
Date submitted for ethics approval [1] 290940 0
17/04/2014
Approval date [1] 290940 0
Ethics approval number [1] 290940 0
HREC 14/QTHS/88

Summary
Brief summary
Aim: To investigate the relationship between dorsal hand/forearm cannulas and the development of an upper limb
DVT in high risk surgical patients.
Our sample size population will include 75 high risk patients (sample size of 62 + 10% for attrition) . Inclusion
criteria are patients with an underlying malignancy, thrombophilias, previous surgery/trauma and over 65 years of
age. As part of the inclusion criteria all patients will receive standard DVT prophylaxis surgery and have baseline
bloods performed including a FBC,LFT, U+E and INR.Patients with a previous upper limb DVT, previous neck
surgery/mastectomy/axillary clearance and thoracic outlet syndrome were excluded. Ultrasounds will be performed
at enrolment (which is part of normal patient care) and at discharge to identify an upper limb DVT. Patients
found to have an upper limb DVT will be placed on DVT protocol for treatment and will be followed up for 30 days for continuing management and monitoring of complications.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 47 47 0 0
/AnzctrAttachments/366258-Study protocol Version 4.docx

Contacts
Principal investigator
Name 48090 0
Miss Amy Leung
Address 48090 0
James Cook University
PO Box 6314
Mackay Mailing Centre
Queensland 4741
Country 48090 0
Australia
Phone 48090 0
+61 (0)448904844
Fax 48090 0
Email 48090 0
[email protected]
Contact person for public queries
Name 48091 0
Miss Amy Leung
Address 48091 0
James Cook University
PO Box 6314
Mackay Mailing Centre
Queensland, 4741
Country 48091 0
Australia
Phone 48091 0
61 (0)448904844
Fax 48091 0
Email 48091 0
[email protected]
Contact person for scientific queries
Name 48092 0
Dr Casper Pretorius
Address 48092 0
Mackay Base Hospital
Bridge Road
Mackay, Queensland 4740
Country 48092 0
Australia
Phone 48092 0
+61 (0)432486757
Fax 48092 0
Email 48092 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.