None listed
Conditions
Brief summary
We intend to undertake a full study (MAIN RCT) consisting of a three-arm parallel groups randomised-controlled trial of low dose aspirin, an intermittent pneumatic compression device commercially known as Jet Impulse Technology (JIT) plus low dose aspirin, or rivaroxaban alone to prevent venous thromboembolism (VTE) secondary to cast immobility for a ruptured Achilles tendon or ankle fracture. For the proposed MAIN RCT to be viable, we need to establish the capacity to recruit, tolerability of JIT placement under a lower limb cast for a protracted period of time (up to 8 weeks), and adherence to the proposed JIT in-cast regime. This feasibility trial has been designed to establish the proportion of subjects likely to enrol in the MAIN RCT, the ease of application and acceptability of the JIT system under a cast, possible adverse events with the JIT system, and the proportion of symptomatic VTE events in the population enrolled in the trial.
Interventions
The Jet Impulse Technology (JIT) system, is supplied by Dickson and Dickson Healthcare (DnD Healthcare) and comprises a VENAjet pump system foot garment.
This is a system that is used regularly for DVT prophylaxis in high risk and immobile patients post-surgery.
The subjects' foot that is intended to be casted will be placed in a foot compression garment (a cuff) that will be attached by tube assembly to a pump unit. When the pump unit is turned on, a distal aircell within the foot cuff will
The Jet Impulse Technology (JIT) system, is supplied by Dickson and Dickson Healthcare (DnD Healthcare) and comprises a VENAjet pump system foot garment. This is a system that is used regularly for DVT prophylaxis in high risk and immobile patients post-surgery. The subjects' foot that is intended to be casted will be placed in a foot compression garment (a cuff) that will be attached by tube assembly to a pump unit. When the pump unit is turned on, a distal aircell within the foot cuff will inflate rapidly to approximately 130mmHg +/-10% and will then settle to 52mmHg, and a proximal aircell follows approximately 0.3 seconds after, to settle at approximately 48mmHg. After 6 seconds of compression at 48-53mmHg, the cuffs deflate. The cycle repeats every minute. The JIT system will be placed on the participants foot, and the cast will be applied over the JIT system. The JIT system is supposed to be used during non-weight bearing so those using the device will be asked to use it while they are seated or immobile during the day and while in bed at night. Information about device usage will be collected at each visit to determine the use of JIT (60%, or 14.4 hours per day average is defined as good adherence). In addition to this intervention, participants will receive the usual care of aspirin EC, 100mg daily. The overall duration of lower limb immobiisation is expected to be a minimum of 4 weeks, out to a maximum of 8 weeks. At weeks 2 and 4 of enrolment, participants will have an above-cast ultrasound of the casted limb to check for asymptomatic deep vein thrombosis (DVT) At approximately 8 weeks (after removal of the limb immobilisation), participants will have a full length lower limb ultrasound to check for asymptomatic DVT.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Aged between 18 and 70 years with - ruptured Achilles tendon or - stable ankle fracture requiring a non-weight bearing cast, or - ankle fracture with operative fixation and then cast immobilisation, or - elective operation of the lower limb subsequently requiring cast immobilisation - Able to provide informed consent
Exclusion criteria
1. History of previous or current DVT or PE 2. Pregnancy 3. Current active cancer, other than basal cell carcinoma of the skin. 4. Known thrombophilic state 5. Already using anticoagulation 6. Use of low molecular weight heparin or immobility greater than two days prior to enrolment. 7. Any other criteria which at the discretion of the investigator will affect the safety of the participant or the participants ability to comply with the requirements of the study
Outcome results
None listed