Pulmonary Embolism Clinical Trial
— RIPTOfficial title:
Retrievable Inferior Vena Cava Filter for Primary Pulmonary Embolism Prophylaxis in At-Risk Trauma Patients: RIPT Feasibility Trial
NCT number | NCT03070834 |
Other study ID # | 108169 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | February 28, 2020 |
Verified date | February 2020 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Victoria Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Antevil JL, Sise MJ, Sack DI, Sasadeusz KJ, Swanson SM, Rivera L, Lome BR, Weingarten KE, Kaminski SS. Retrievable vena cava filters for preventing pulmonary embolism in trauma patients: a cautionary tale. J Trauma. 2006 Jan;60(1):35-40. — View Citation
Carlin AM, Tyburski JG, Wilson RF, Steffes C. Prophylactic and therapeutic inferior vena cava filters to prevent pulmonary emboli in trauma patients. Arch Surg. 2002 May;137(5):521-5; discussion 525-7. — View Citation
Decousus H, Leizorovicz A, Parent F, Page Y, Tardy B, Girard P, Laporte S, Faivre R, Charbonnier B, Barral FG, Huet Y, Simonneau G. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombos — View Citation
Geerts WH, Code KI, Jay RM, Chen E, Szalai JP. A prospective study of venous thromboembolism after major trauma. N Engl J Med. 1994 Dec 15;331(24):1601-6. — View Citation
Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, Samama CM. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical P — View Citation
Haut ER, Garcia LJ, Shihab HM, Brotman DJ, Stevens KA, Sharma R, Chelladurai Y, Akande TO, Shermock KM, Kebede S, Segal JB, Singh S. The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis. JA — View Citation
Karmy-Jones R, Jurkovich GJ, Velmahos GC, Burdick T, Spaniolas K, Todd SR, McNally M, Jacoby RC, Link D, Janczyk RJ, Ivascu FA, McCann M, Obeid F, Hoff WS, McQuay N Jr, Tieu BH, Schreiber MA, Nirula R, Brasel K, Dunn JA, Gambrell D, Huckfeldt R, Harper J, — View Citation
Kirilcuk NN, Herget EJ, Dicker RA, Spain DA, Hellinger JC, Brundage SI. Are temporary inferior vena cava filters really temporary? Am J Surg. 2005 Dec;190(6):858-63. — View Citation
Knudson MM, Ikossi DG, Khaw L, Morabito D, Speetzen LS. Thromboembolism after trauma: an analysis of 1602 episodes from the American College of Surgeons National Trauma Data Bank. Ann Surg. 2004 Sep;240(3):490-6; discussion 496-8. — View Citation
Leeper WR, Murphy PB, Vogt KN, Leeper TJ, Kribs SW, Gray DK, Parry NG. Are retrievable vena cava filters placed in trauma patients really retrievable? Eur J Trauma Emerg Surg. 2016 Aug;42(4):459-464. doi: 10.1007/s00068-015-0553-5. Epub 2015 Jul 23. — View Citation
O'Malley KF, Ross SE. Pulmonary embolism in major trauma patients. J Trauma. 1990 Jun;30(6):748-50. — View Citation
Owings JT, Kraut E, Battistella F, Cornelius JT, O'Malley R. Timing of the occurrence of pulmonary embolism in trauma patients. Arch Surg. 1997 Aug;132(8):862-6; discussion 866-7. — View Citation
PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation. 2005 Jul 19;112(3):4 — View Citation
Rogers FB, Cipolle MD, Velmahos G, Rozycki G, Luchette FA. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma. 2002 Jul;53(1):142-64. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time left unprotected to venous thromboembolism | 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. | two weeks post trauma | |
Secondary | Venous Thromboembolism | 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. | in hospital (up to one year) | |
Secondary | Mortality | in hospital death | In Hospital (up to one year) | |
Secondary | Filter Feasibility Outcome: Time to filter insertion | 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) | hours to weeks, up to one year | |
Secondary | Filter Feasibility Outcome: Time to filter removal | b) time to filter removal (defined as time from rIVCF insertion, to removal) | hours to weeks, up to one year | |
Secondary | Filter Feasibility Outcome: Filter retrieval rate | 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) | hours to weeks, up to one year | |
Secondary | Rates of worsening intracranial bleed | 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) | up to 2 weeks |
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