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RIPT Feasibility Trial (RIPT)

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ClinicalTrials.gov Identifier: NCT03070834
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:

The risk of venous thromboembolism (VTE) is very high in trauma patients, secondary to tissue injury, venous status from immobilization, and thrombophilia. As such, early initiation of VTE prophylaxis is essential in this population. The competing risks of life threatening hemorrhage and VTE need to be considered very carefully. Potential approaches to VTE prophylaxis include pharmacologic means, and mechanical devices. For patients unable to receive pharmacologic VTE prophylaxis, retrievable inferior vena cava filters (rIVCFs) may be placed until low molecular weight heparin (LMWH) can be initiated, as per guidelines such as Eastern Association for the Surgery of Trauma

The investigators propose a feasibility study to determine whether or not our center can insert rIVCFs in at-risk trauma patients expeditiously enough to cause a meaningful reduction in the time they are left unprotected to PE.


Condition or disease Intervention/treatment Phase
Pulmonary Embolism Trauma Venous Thromboembolism Device: Cook 'Celect' retrievable inferior vena cava filter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retrievable Inferior Vena Cava Filter for Primary Pulmonary Embolism Prophylaxis in At-Risk Trauma Patients: RIPT Feasibility Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : February 16, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rIVCF
Randomized to receive insertion of retrievable inferior vena cava filter until chemical anticoagulation can be safely administered.
Device: Cook 'Celect' retrievable inferior vena cava filter
Cook 'Celect' device will be deployed If randomized to rIVCF insertion

No Intervention: Standard Care
Randomized to not receive insertion of retrievable inferior vena cava filter.



Primary Outcome Measures :
  1. Time left unprotected to venous thromboembolism [ Time Frame: two weeks post trauma ]
    time left unprotected to pulmonary embolism two weeks post arrival to hospital defined as: time point from arrival to LHSC to two weeks after, measured in hours where-in patient either has no rIVCF in situ, or has no regular low molecular weight heparin (LMWH) on board. missed doses of LMWH > 2 hours within planned administration time will count toward primary outcome. If LMWH is held for operative intervention, time left held > 24 hours post previous dose will count toward the primary outcome.


Secondary Outcome Measures :
  1. Venous Thromboembolism [ Time Frame: in hospital (up to one year) ]
    1. Incidence of symptomatic/clinically impactful pulmonary embolism (as defined by result of computed tomography pulmonary angiogram, autopsy, or ventilation perfusion scan, reported by a radiologist and ordered at the discretion of the MRP on clinical grounds.

  2. Mortality [ Time Frame: In Hospital (up to one year) ]
    in hospital death

  3. Filter Feasibility Outcome: Time to filter insertion [ Time Frame: hours to weeks, up to one year ]
    a) time to filter insertion (defined as time from arrival to London Health Sciences Cente, to time of insertion of rIVCF as documented on the procedure note) b) time to filter removal (defined as time from rIVCF insertion, to removal) c) filter retrieval rate (percentage of patients who receive rIVCF who have rIVCF extraction, will track all patients through follow-up in Trauma Clinic upon discharge if they still have their devices in-situ)

  4. Filter Feasibility Outcome: Time to filter removal [ Time Frame: hours to weeks, up to one year ]
    b) time to filter removal (defined as time from rIVCF insertion, to removal)

  5. Filter Feasibility Outcome: Filter retrieval rate [ Time Frame: hours to weeks, up to one year ]
    c) filter retrieval rate (percentage of patients who receive rIVCF who have rIVCF extraction, will track all patients through follow-up in Trauma Clinic upon discharge if they still have their devices in-situ)

  6. Rates of worsening intracranial bleed [ Time Frame: up to 2 weeks ]
    5) rates of worsening intracranial haemorrhage within patients: Defined as the change in cubic volume of the documented hematoma found in serial computed tomography investigations (if done so as part of routine care)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consecutive age adult trauma patients who are:

    1. Deemed unable to receive medial VTE prophylaxis within 72 hours post injury based on traumatologists' suspicion of increased bleeding risk, peri-spinal cord bleeding risk, or need for multiple surgical interventions.

      AND

    2. have at-least on of the following high risk VTE injuries as per EAST Guidelines:

      1. severe closed head injury (GCS 8 or less upon presentation)
      2. incomplete spinal cord injury with paraplegia or quadriplegia
      3. complex pelvic fracture with associated long bone fracture(s)
      4. multiple long bone fractures

Exclusion Criteria:

  1. Patients not expected to survive for at least 72 hours post trauma
  2. Patients with known uncorrectable coagulopathy
  3. Patients known to be unable to receive a rIVC filter as part of this trial (for anatomical reasons or standard contraindication for device insertion)
  4. Known active venous thromboembolic disease
  5. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070834


Contacts
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Contact: Ian Ball 5196858500 ext 71513 ian.ball@lhsc.on.ca

Locations
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Canada, Ontario
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Ian Ball    519 685 8500 ext 71513    ian.ball@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03070834    
Other Study ID Numbers: 108169
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pulmonary Embolism
Thromboembolism
Embolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases