RIPT Feasibility Trial

NCT03070834 | Completed FDA Device

• 1 other identifier: 108169
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism; Trauma; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Venous Thromboembolism

  in hospital (up to one year)

• Mortality

  In Hospital (up to one year)

• Filter Feasibility Outcome: Time to filter insertion

  hours to weeks, up to one year

• Filter Feasibility Outcome: Time to filter removal

  hours to weeks, up to one year

• Filter Feasibility Outcome: Filter retrieval rate

  hours to weeks, up to one year

Study Arms (2)

rIVCF

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Randomized to not receive insertion of retrievable inferior vena cava filter.

Interventions

Cook 'Celect' retrievable inferior vena cava filter DEVICE

Cook 'Celect' device will be deployed If randomized to rIVCF insertion

rIVCF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive age adult trauma patients who are:
• 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
• have at-least on of the following high risk VTE injuries as per EAST Guidelines:
• severe closed head injury (GCS 8 or less upon presentation)
• incomplete spinal cord injury with paraplegia or quadriplegia
• complex pelvic fracture with associated long bone fracture(s)
• multiple long bone fractures

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Related Publications (15)

• 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. doi: 10.1056/NEJM199412153312401.

  PMID: 7969340 RESULT

• 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. doi: 10.1001/archsurg.1997.01430320064010.

  PMID: 9267270 RESULT

• O'Malley KF, Ross SE. Pulmonary embolism in major trauma patients. J Trauma. 1990 Jun;30(6):748-50. doi: 10.1097/00005373-199006000-00018.

  PMID: 2352304 RESULT

• 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. doi: 10.1001/archsurg.137.5.521.

  PMID: 11982463 RESULT

• 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. JAMA Surg. 2014 Feb;149(2):194-202. doi: 10.1001/jamasurg.2013.3970.

  PMID: 24195920 RESULT

• 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. doi: 10.1097/00005373-200207000-00032. No abstract available.

  PMID: 12131409 RESULT

• 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 Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e227S-e277S. doi: 10.1378/chest.11-2297.

  PMID: 22315263 RESULT

• 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. doi: 10.1097/01.sla.0000137138.40116.6c.

  PMID: 15319720 RESULT

• 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. doi: 10.1016/j.amjsurg.2005.08.009.

  PMID: 16307934 RESULT

• 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. doi: 10.1097/01.ta.0000197607.23019.ab.

  PMID: 16456434 RESULT

• 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, Schaffer KB, Tominaga GT, Vinces FY, Sperling D, Hoyt D, Coimbra R, Rosengart MR, Forsythe R, Cothren C, Moore EE, Haut ER, Hayanga AJ, Hird L, White C, Grossman J, Nagy K, Livaudais W, Wood R, Zengerink I, Kortbeek JB. Practice patterns and outcomes of retrievable vena cava filters in trauma patients: an AAST multicenter study. J Trauma. 2007 Jan;62(1):17-24; discussion 24-5. doi: 10.1097/TA.0b013e31802dd72a.

  PMID: 17215729 RESULT

• 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 thrombosis. Prevention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15. doi: 10.1056/NEJM199802123380701.

  PMID: 9459643 RESULT

• 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):416-22. doi: 10.1161/CIRCULATIONAHA.104.512834. Epub 2005 Jul 11.

  PMID: 16009794 RESULT

• 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.

  PMID: 26201391 RESULT

• Young T, Sriram KB. Vena caval filters for the prevention of pulmonary embolism. Cochrane Database Syst Rev. 2020 Oct 8;10(10):CD006212. doi: 10.1002/14651858.CD006212.pub5.

  PMID: 33027844 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Wounds and Injuries; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 6, 2017
• Study Start: July 1, 2017
• Primary Completion: February 16, 2020
• Study Completion: February 28, 2020
• Last Updated: March 1, 2021

Record last verified: 2020-02

Locations

CA (1)