Deep Vein Thrombosis
Conditions
Brief summary
This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.
Interventions
DEVICEgeko™ post-surgery for 48hrs then 4hrs/day until discharge.
DEVICETEDS post-surgery for 48hrs then 4hrs/day until discharge.
Sponsors
Firstkind Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years of age and over 2. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders). 3. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment. 4. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form. 5. Able and willing to follow the protocol requirements.
Exclusion criteria
1. Are requiring hip revision surgery 2. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism. 3. Evidence of asymptomatic DVT by Duplex Ultrasound 4. Peripheral arterial disease (ABPI \< 0.8), varicose veins or lower limb ulceration or ischemia. 5. Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2 6. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement). 7. Recent trauma to lower limb. 8. Chronic Obesity (BMI Index \>40kg/m2). 9. Pregnancy. 10. Significant history of following diseases I. Cardiovascular: Recent MI (\< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (\< 3 months for Bare Metal Stent (BMS) and \< 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted. VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders 11. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin 12. Long term steroid with dermatological changes 13. A pulse rate of less than 40 beats/minute 14. A sitting systolic blood pressure \>180 and \<100 mmHg and/or a sitting diastolic pressure of \>100 mmHg. 15. Any significant illness during the four (4) weeks preceding the hip replacement surgery. 16. Participation in any clinical study during the eight (8) weeks preceding the screening period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of asymptomatic DVT assessed by Duplex Ultrasound | 6 weeks |
Countries
United Kingdom
Outcome results
None listed