AzTrials
AzTrials

TraumaPhase 2GIFT PilotNCT01835990

Feasibility Study of Geko vs. IPCs in Trauma

A Phase 2 study testing geko and IPCs in people with Trauma and Venous Thromboembolism, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Trauma patients are at a high risk of developing blood clots in the legs (deep vein thrombosis - DVT), which can travel to the lungs and cause serious health consequences. Often, these patients cannot receive blood-thinning medication to prevent these blood clots because of the risk of bleeding; in this case, they are… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trauma, Venous Thromboembolism
What is being tested?
geko and IPCs
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
Jul 2013to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of trauma, meeting criteria for referral to the HHS trauma service - ANY of the following (1-3):
  • patient with obvious major injuries in two or more systems, each requiring a specialist and inpatient care
  • spinal injury with paraplegia or tetraplegia; severe penetrating injury to the head, neck, trunk or groin; amputation above the wrist or ankle; burns, second or third degree, involving 20% or more body surface area, or involving the face or genitalia
  • Glasgow Coma Scale (GCS) less than or equal to 10, as a result of trauma or any two of:
  • significant decrease in level of consciousness
  • pulse < 50 or > 120
Show all 13Show fewer
  • BP < 80 or absent radial pulse
  • Respiratory rate < 10 or > 24
  • Subject admitted to the Hamilton General Hospital ICU or the hospital ward step-down units
  • Age 18 years or older
  • Contraindication to anticoagulation expected to last for more than 3 days. Contraindication to anticoagulation may include intracranial hemorrhage, ocular injury with associated hemorrhage, solid intra-abdominal organ injury (i.e. liver, spleen, kidney), and/or pelvic or retroperitoneal hematoma requiring transfusion. [12] The final determination of whether anticoagulant prophylaxis is contraindicated will be made by the treating physician.
  • Projected hospitalization greater than 3 days (as determined by treating physician)
  • Informed consent can be provided by the subject or substitute decision maker within 48 hours of admission

Who cannot join

  • Inability to wear either IPCs or gekoTM on both legs, including but not limited to:
  • unstable fracture of the lower extremity;
  • compartment syndrome of the lower extremity;
  • skin breakdown affecting the area on which the devices will be applied;
  • prior amputation affecting the area on which the devices will be applied;
  • severe peripheral ischemic vascular disease;
Show all 20Show fewer
  • uncontrolled bleeding of the lower extremity;
  • Diagnosis of DVT within 1 month prior to assessment for enrollment
  • Use of anticoagulant medication within 24h of enrollment (except when used solely as a flush for intravenous catheters), or ongoing effect of anticoagulant medication at time of enrollment as determined by history of medication use and laboratory evidence of medication effect. For the purposes of this study, anticoagulant medications include:
  • unfractionated heparin (intravenous or subcutaneous)
  • low molecular weight heparin
  • fondaparinux
  • dabigatran
  • rivaroxaban
  • warfarin
  • argatroban
  • danaparoid
  • lepirudin
  • Leg circumference greater than 24 inches at the location the gekoTM device would be secured to the leg.
  • Presence of cardiac demand pacemaker

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: Feasibility Study of a Randomized Controlled Trial of a Novel Device vs. Intermittent Pneumatic Compression for Prevention of Venous Thromboembolism in Trauma Patients

Trauma patients are at a high risk of developing blood clots in the legs (deep vein thrombosis - DVT), which can travel to the lungs and cause serious health consequences. Often, these patients cannot receive blood-thinning medication to prevent these blood clots because of the risk of bleeding; in this case, they are usually given intermittent pneumatic compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over the legs and periodically inflate and deflate, helping to pump blood out of the legs and thus reduce the risk of blood clot formation. Several studies suggest that IPCs are working properly on the patient only 60-70% of the time. Some patients also find them uncomfortable. A new device (geko) that works by stimulating the leg muscles and increasing blood flow in the legs has recently been developed. To compare the geko with IPCs, this study will randomly assign trauma patients who cannot receive blood thinners for blood clot prevention to either IPCs or geko. The main goal is to determine the feasibility of doing a larger study which would compare the efficacy of these devices in preventing blood clots. The amount of time the devices are properly used on the patients, comfort and tolerability, development of blood clots, and blood flow in the leg veins and arteries will also be measured and compared between the devices.

Being tested
geko, IPCs
Keywords
venous thromboembolism, trauma, mechanical methods of prophylaxis
Medical subject headings
Wounds and Injuries, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gekoDevice

    Also called neuromuscular stimulation device

    The geko is a neuromuscular stimulation device that stimulates the common peroneal nerve resulting in contraction of the leg muscles and increased venous and arterial flow. It is Health Canada approved for prevention of deep venous thrombosis.

  • IPCsDevice

    Also called intermittent pneumatic compression devices, Arjo Huntleigh Flowtron

    devices that pneumatically compress the leg, resulting in increased venous blood flow.

Study groups in NCT01835990
Study groupRoleWhat they receive
gekoExperimentalFor subjects randomized to the experimental treatment arm, one gekoTM device will be applied to each leg according to the manufacturer's instructions by the subject's primary care nurse. All nurses applying the devices must be trained on proper application technique. The old devices will be removed and new devices applied daily. The subject will continue to use the devices until he or she exits the study.
Receives: Device: geko
IPCsActive comparatorThe control treatment will consist of the hospital's standard IPC devices. The IPCs will be applied to each leg by the subject's primary care nurse according to the manufacturer's instructions. They will continue to be applied until exit from the study. At the time of withdrawal from the study, the decision regarding continued use of IPCs will be made by the treating physician.
Receives: Device: IPCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of completing a larger, phase III trial with DVT incidence as primary outcome

    This endpoint will be considered to have been met if, after enrollment of 40 subjects, both of the following conditions are met:

    1. the time from enrollment of the first subject to enrollment of the 40th subject is less than 18 months; AND ii. all secondary outcomes are evaluable for at least 80% of subjects.

    Measured: earliest of when 40th subject is enrolled or 18 months from study start

Secondary outcomes (4)

  1. Compliance

    Study personnel will assess compliance. For subjects randomized to gekoTM, the subject will be considered compliant for the visit if:

    1. one gekoTM device is attached to each leg; AND ii) a muscle contraction caused by each device can be visualized with the subject's leg at rest;

    For subjects randomized to IPCs, the subject will be considered compliant for the visit if:

    1. one calf sleeve is affixed to each leg; AND ii) both sleeves are visibly inflating and deflating.

    A compliance statistic will be computed for each subject by dividing the number of compliant observations by the total number of observations. A mean value will be determined for each study arm. The means will be compared using a two-tailed Student's t-test with alpha = 0.05. The proportion of subjects with a compliance statistic of at least 80% will be calculated. The proportion of subjects with at least 80% compliance will be compared between study treatment arms using Fisher's exact test.

    Measured: Twice daily (excluding weekends and holidays), until subject exits study

  2. Development of venous thromboembolism

    Development of VTE defined either by 1) a positive screening duplex ultrasound of the deep veins of the legs, or 2) an objectively verified clinical diagnosis of DVT and/or PE, established by patient's treating physician.

    The proportion of patients in each arm who develop VTE during the study will be calculated. The sample is projected to be too low to enable any further statistical comparison of efficacy in prevention of VTE.

    Measured: At time subject exits from study (day 10 or earlier)

  3. Tolerability

    The tolerability questionnaire will be administered by the research coordinator on the day of study exit.

    The proportion of subjects selecting each of the possible answers for each of the questions on the tolerability questionnaire will be computed for each study arm. Further statistical comparison between the groups will not be undertaken for the tolerability questionnaire, but the data will be used for hypothesis-generation regarding specific causes of increased or decreased tolerability between the devices.

    Measured: At time subject exits from study (day 10 or earlier)

  4. Venous and arterial physiological flow

    Mean values and standard error for each study arm will be computed for the volume flow and peak velocity in the superficial femoral vein and femoral artery using pulsed Doppler by duplex ultrasound.

    The values will be compared using a two-tailed Student's t-test (alpha = 0.05).

    Measured: At time subject exits from study (day 10 or earlier)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01835990
Sponsor's protocol ID
GIFT Pilot
Acronym
GIFT Pilot
Status last verified
Mar 2015
First submitted
17 Dec 2012
Last updated
19 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing geko and IPCs in people with Trauma and Venous Thromboembolism, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of completing a larger, phase III trial with DVT incidence as primary outcome (time frame: earliest of when 40th subject is enrolled or 18 months from study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01835990.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in