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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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)
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
|Contact: Ian Ball||5196858500 ext email@example.com|
|London, Ontario, Canada, N6A 5W9|
|Contact: Ian Ball 519 685 8500 ext 71513 firstname.lastname@example.org|