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Feasibility Study of Geko vs. IPCs in Trauma (GIFT Pilot)

Primary Purpose

Trauma, Venous Thromboembolism

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

geko

IPCs

About this trial

This is an interventional prevention trial for Trauma focused on measuring venous thromboembolism, trauma, mechanical methods of prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of trauma, meeting criteria for referral to the HHS trauma service - ANY of the following (1-3):
1. patient with obvious major injuries in two or more systems, each requiring a specialist and inpatient care
2. 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
3. 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
  - 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

Exclusion Criteria:

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;
- 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

Sites / Locations

Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

geko

IPCs

Arm Description

For 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.

The 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.

Outcomes

Primary Outcome Measures

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: i. 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.

Secondary Outcome Measures

Compliance

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

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.

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.

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).

Full Information

NCT ID

NCT01835990

First Posted

December 17, 2012

Last Updated

March 18, 2015

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01835990

Brief Title

Feasibility Study of Geko vs. IPCs in Trauma

Acronym

GIFT Pilot

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trauma, Venous Thromboembolism

Keywords

venous thromboembolism, trauma, mechanical methods of prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

geko

Arm Type

Experimental

Arm Description

Arm Title

IPCs

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

geko

Other Intervention Name(s)

neuromuscular stimulation device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

IPCs

Other Intervention Name(s)

intermittent pneumatic compression devices, Arjo Huntleigh Flowtron

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Compliance

Description

Time Frame

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

Title

Development of venous thromboembolism

Description

Time Frame

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

Title

Tolerability

Description

Time Frame

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

Title

Venous and arterial physiological flow

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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; 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vinai C Bhagirath, MD FRCP(C)

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

12. IPD Sharing Statement

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Feasibility Study of Geko vs. IPCs in Trauma

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