Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2016 by Firstkind Ltd
Sponsor:
Firstkind Ltd
Information provided by (Responsible Party):
Firstkind Ltd
ClinicalTrials.gov Identifier:
NCT01935414
First received: August 28, 2013
Last updated: March 8, 2016
Last verified: March 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Deep Vein Thrombosis |
Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge. Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Multicentre Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between the gekoTM Device and Thromboembolism Deterrent Stockings in Patients Recovering From Total Hip Replacement Surgery |
Resource links provided by NLM:
Further study details as provided by Firstkind Ltd:
Primary Outcome Measures:
- Presence of asymptomatic DVT assessed by Duplex Ultrasound [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2013 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: geko™
geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
|
Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge. |
|
Active Comparator: TEDS stockings
TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge
|
Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged 18 years of age and over
- Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
- 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.
- Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
- Able and willing to follow the protocol requirements.
Exclusion Criteria:
- Are requiring hip revision surgery
- History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- Evidence of asymptomatic DVT by Duplex Ultrasound
- Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
- Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
- Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
- Recent trauma to lower limb.
- Chronic Obesity (BMI Index >40kg/m2).
- Pregnancy.
-
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
- On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
- Long term steroid with dermatological changes
- A pulse rate of less than 40 beats/minute
- A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
- Any significant illness during the four (4) weeks preceding the hip replacement surgery.
- Participation in any clinical study during the eight (8) weeks preceding the screening period
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935414
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935414
Contacts
| Contact: Matthew Womack, PhD | +44(0) 7456427910 | matthew.womack@firstkindmedical.com |
Locations
| United Kingdom | |
| BMI The Harbour Hospital | Recruiting |
| Poole, Dorset, United Kingdom, BH15 2BH | |
Sponsors and Collaborators
Firstkind Ltd
More Information
Additional Information:
| Responsible Party: | Firstkind Ltd |
| ClinicalTrials.gov Identifier: | NCT01935414 History of Changes |
| Other Study ID Numbers: | FKD-TEDS-001 |
| Study First Received: | August 28, 2013 |
| Last Updated: | March 8, 2016 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Thrombosis Thromboembolism Venous Thrombosis |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 23, 2016