Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935414
• Other study ID #: FKD-TEDS-001
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: November 16, 2016

Study information

• Verified date: August 2022
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 16, 2016
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thromboembolism
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• geko™ post-surgery for 48hrs then 4hrs/day until discharge.

• TEDS post-surgery for 48hrs then 4hrs/day until discharge.

Locations

Country	Name	City	State
United Kingdom	BMI The Harbour Hospital	Poole	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of asymptomatic DVT assessed by Duplex Ultrasound		6 weeks

External Links

•   Company website