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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

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE March 6, 2017
Last Update Posted Date February 21, 2020
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date February 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • 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.
  • Mortality [ Time Frame: In Hospital (up to one year) ]
    in hospital death
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • 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.
  • Mortality [ Time Frame: In Hospital (up to one year) ]
    in hospital death
  • Filter Feasibility Outcomes [ 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)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RIPT Feasibility Trial
Official Title  ICMJE Retrievable Inferior Vena Cava Filter for Primary Pulmonary Embolism Prophylaxis in At-Risk Trauma Patients: RIPT Feasibility Trial
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.

Detailed Description

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.

The need for mechanical VTE prophylaxis in patients unable to receive pharmacologic therapy is underscored by Geerts and colleagues' prospective study of trauma patients who did not receive anticoagulation. In their study, 58% of their 349 trauma patients sustained deep venous thromboses (DVT). [Geerts et a., 1994] Furthermore, a confirmed or clinically suspected pulmonary embolus (PE) was identified in an additional 5% of patients. Importantly, this study excluded patients who died during the first 5 days of admission. However, the highest risk of VTE occurs in the first 4 days after admission and many advocate early insertion of rIVCF [Owings et al. 1997, O'Malley et al. 1990, Carlin et al. 2002, Haut et al. 2014]. Coincidentally, VTE prophylaxis is often withheld pending repeat neurologic imaging and / or surgical intervention.

Current guidelines on the use of rIVCFs are contradictory. The Eastern Association for the Surgery of Trauma's (EAST) practice management guideline suggests the use of rIVCFs are advisable in the "very-high-risk trauma patients". Such patients are defined as the those who cannot receive anticoagulation because of increased bleeding risk and have sustained injuries preventing mobilization such as: i) severe closed head injury (GCS < 8) ii) incomplete spinal cord injury with paraplegia or quadriplegia iii) complex pelvic fracture with associated long bone fractures iv) multiple long bone fractures [Rogers et al 2002]. Contrasting this, the American College of Chest Physicians sated in their 2012 Guideline, that there is no role for rIVCFs in primary VTE prevention. [Gould et al. 2012]

Reflecting this lack of consensus in guidelines, there is practice variability among major trauma centres. In an American based survey study of 131 Trauma Directors, LMWH was the preferred method for VTE prophylaxis in over half (51%) of the responders, followed by intermittent pneumatic compression devices (IPCD, 42%), Foot pump (8%) Low Dose Heparin (LDH, 7%) and rIVCFs (1%). In patients with contraindications to pharmacologic prophylaxis, the favoured approach for VTE Prophylaxis is IPCD (80%) followed by rIVCF (16%) and foot pump (9%). [Knudson et al. 2004] More work is needed to improve our understanding of the optimal role for rIVCFs, particularly considering recent advances in, and physician experience with rIVCF technology.

One of the most cited concerns with the use of rIVCF in trauma patients is the low reported retrieval rates ranging from 21-35% of patients. [Kirilcuk et al. 2005, Antevil et al. 2006, Karmy-Jones et al., 2007] The need for VTE prophylaxis in trauma patients is usually temporary, and long term filter use is associated with an increased VTE risk, which was demonstrated in the PREPIC-1 trial and the 8-year follow up study examining the use of permanent IVCF in non-trauma patients with DVT for PE prevention [Decousus et al. 1998, PREPIC Study Group, 2005]. Of note, these trials were examining the role of rIVCF in patients for secondary prophylaxis in at risk patients with known VTE disease. The low retrieval rates of rIVCFs that have been reported in the Unites States are not a problem in our Canadian Lead Trauma Centre. We recently demonstrated a 97% retrieval rate in trauma patients surviving to discharge. [Leeper et al. 2015] We advocate a trial of early rIVCF use followed by prompt removal once medical prophylaxis is safe.

There is a paucity of data regarding the use of rIVCFs in the Canadian setting, and our group is currently surveying Canadian trauma directors to improve our understanding of current practice. Despite the current deficiency of evidence, many Level 1 North American Trauma centres use rIVCF for primary VTE prophylaxis in their at risk trauma patients, as per EAST guidelines. In a recent meta-analysis by Haut et al. that reviewed 8 studies, they identified a reduction in PE incidence with rIVCF use, but concluded that further studies are required. [Haut et al. 2014]

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Embolism
  • Trauma
  • Venous Thromboembolism
Intervention  ICMJE Device: Cook 'Celect' retrievable inferior vena cava filter
Cook 'Celect' device will be deployed If randomized to rIVCF insertion
Study Arms  ICMJE
  • Experimental: rIVCF
    Randomized to receive insertion of retrievable inferior vena cava filter until chemical anticoagulation can be safely administered.
    Intervention: Device: Cook 'Celect' retrievable inferior vena cava filter
  • No Intervention: Standard Care
    Randomized to not receive insertion of retrievable inferior vena cava filter.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date February 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ian Ball 5196858500 ext 71513 ian.ball@lhsc.on.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070834
Other Study ID Numbers  ICMJE 108169
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lawson Health Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP