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Trial registered on ANZCTR


Registration number
ACTRN12619000481178
Ethics application status
Approved
Date submitted
15/03/2019
Date registered
22/03/2019
Date last updated
12/04/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised clinical trial to assess the feasibility for a larger study comparing the use of three Veno-Thrombo-Embolic prophylaxis treatments in patients undergoing major abdominal surgery.
Scientific title
Randomised clinical trial to assess the feasibility for a larger study comparing the use of three Veno-Thrombo-Embolic prophylaxis treatments in patients undergoing major abdominal surgery.
Secondary ID [1] 297720 0
JHHGIS13
Universal Trial Number (UTN)
Trial acronym
VET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis (DVT) 312044 0
Pulmonary Embolism (PE) 312045 0
Condition category
Condition code
Surgery 310607 310607 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to surgery the patient will be randomised to either the intervention or control group. When in the operating theatre the intervention group will have compressions stockings plus low molecular weight heparin plus intermittent pneumatic compression devices placed on their legs and device commenced. The control group will have only have the compression stockings and standard dose of Low molecular weight heparin. After surgery both groups will follow standard treatment. IPCDs are a therapeutic technique used in medical devices that include an air pump and inflatable auxiliary sleeves in a system designed to improve venous circulation in the limbs of patients who suffer edema or the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). The intervention group will have the intermittent pneumatic devices still on legs and only taken off for walking and showering. The standard dose of low molecular weight heparin (LMWH) is 40mg by subcutaneous injection once a day for the length of hospital stay. IPCDs are a therapeutic technique used in medical devices that include an air pump and inflatable auxiliary sleeves in a system designed to improve venous circulation in the limbs of patients who suffer edema or the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). Compression stockings are elastic garments worn around the leg, compressing the limb. This reduces the diameter of distended veins and increases venous blood flow velocity and valve effectiveness. Knee-high compression stockings are used not only to help increase circulation, but also to help prevent the formation of blood clots in the lower legs. The GCS in both groups are to be worn at all times except when showering or if soiled. The IPCDs are to be removed if walking, showering or soiled and in this case need to be replaced. The group wearing the IPCDs will not have to them after discharge. Both groups will be advised to continue wearing the GCS for four weeks post discharge.

Prior to discharge both groups will have follow-up bilateral ultrasounds of lower legs at a vascular lab at day 30. A letter to the GP will be sent to explain the patient is in this study if they present with signs of a deep vein thrombosis or pulmonary embolism. One week prior to the ultrasound a research team member will ring the patient to remind them of appointment and organise transport if needed. Following the ultrasound 2 vascular surgeons will be reporting on the scans and will immediately ring the research team. If at any time the patient is symptomatic they will be advised to wither go to the closet emergency department or their GP to organise a scan.
Intervention code [1] 313960 0
Treatment: Devices
Intervention code [2] 314008 0
Treatment: Drugs
Comparator / control treatment
Control- pharmaceutical prophylaxis + compression stockings
Control group
Active

Outcomes
Primary outcome [1] 319458 0
How many participants out of the 30 can we get to the 30 day Ultrasound Scan
Timepoint [1] 319458 0
30 day Ultrasound Scan follow-up
Secondary outcome [1] 368257 0
Review of hospital medical record for admission with diagnosis of PE or VTE
Timepoint [1] 368257 0
up to day 30

Eligibility
Key inclusion criteria
All patients 40 years and over undergoing elective major abdominal surgery with an anticipated length of stay greater than 24 hours and able to attend a 30-day follow-up bilateral lower leg venous ultrasound.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients from the above group will be excluded if they have:
• Unable to give written informed consent to take part in the study,
• Active, clinically significant bleeding
• Documented congenital or acquired bleeding tendency/disorders
• Recent intracranial hemorrhage or recent (less than 3 months prior to randomization) brain spinal, or ophthalmologic surgery
• Patients where epidural or spinal anesthesia is planned and undertaken.
• Known cerebral metastasis
• Participants in whom haemostasis had not been established 6 hours after surgical closure
• Current thrombocytopenia eg platelets <70
• Renal Impairment GFR <30 and or Creatinine level above 2.0 mg/dL (180 µmol/L) in a well-hydrated participants
• Pregnant and breastfeeding women
• Participant with evidence of leg ischemia caused by peripheral vascular disease, unable to wear IPCD and graduated compression stockings.
• Participants life expectancy < 6 months,
• Clinical sign of VTE and/or history of recent VTE
• Participants who have pre-existing indication for heparins (including LMWH)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil possible
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
Recruitment hospital [1] 13415 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 26017 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 302249 0
Hospital
Name [1] 302249 0
John Hunter Hospital
Address [1] 302249 0
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country [1] 302249 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Local Health District
Address
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 302110 0
None
Name [1] 302110 0
Address [1] 302110 0
Country [1] 302110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302925 0
Hunter New England Human Research Committee
Ethics committee address [1] 302925 0
Locked Bag 1
New Lambton
NSW 2305
Ethics committee country [1] 302925 0
Australia
Date submitted for ethics approval [1] 302925 0
Approval date [1] 302925 0
26/11/2018
Ethics approval number [1] 302925 0
18/09/19/3.02

Summary
Brief summary
One of the risks of having surgery is the formation of a blood clot in a vein in the body. These may form in the deep veins in the legs especially, this kind of clot is called a “thrombus” and if it moves to another part of the body it is then called an “embolus”. Developing a blood clot is a major complication of surgery and at its worst may be life-threatening, and at its best in some cases you may not even know you have a clot as there are no signs and symptoms.
Part of the usual care of a person having a surgical procedure is to try and stop these clots forming by using 3 treatments or a combination of these 3 treatments:
• Compression stockings (commonly known as TED stockings)
• Intermittent pneumatic compression devices (IPCDs). These are disposable and inflatable “sleeves” and are applied to your legs at the time of operation by wrapping around your lower legs and are connected to a pump to inflate and deflate continuously to help move blood from your lower legs back to your heart.
• Injection of an anti-blood clotting drug called Clexane® under the skin daily, up to 28 days from surgery (extended Clexane® injections is not for all patients).

For this “pilot” the research team are wanting to know if they are able to get sufficient patients to a 30 day ultrasound of both legs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91866 0
A/Prof Stephen Smith
Address 91866 0
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre
NSW 2305
Country 91866 0
Australia
Phone 91866 0
+61 2 49236397
Fax 91866 0
Email 91866 0
HNELHD-SurgeryResearch@hnehealth.nsw.gov.au
Contact person for public queries
Name 91867 0
Ms Rosemary Carroll
Address 91867 0
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre
NSW 2305
Country 91867 0
Australia
Phone 91867 0
+61 2 49236397
Fax 91867 0
Email 91867 0
HNELHD-SurgeryResearch@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 91868 0
A/Prof Stephen Smith
Address 91868 0
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre
NSW 2305
Country 91868 0
Australia
Phone 91868 0
+61 2 49236397
Fax 91868 0
Email 91868 0
HNELHD-SurgeryResearch@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot study only
What supporting documents are/will be available?
No other documents available
Summary results
No Results