R Mason Curtis1, Kelly Vogt2, Neil Parry3, Fran Priestap4, W Robert Leeper5, Amol Mujoomdar6, Stewart Kribs7, Ian M Ball8. 1. Department of Medicine, Schulic School of Medicine and Dentistry, Trauma Program, London Health Sciences Center, London, ON, Canada. Electronic address: rmason.curtis@lhsc.on.ca. 2. Department of Surgery, Schulic School of Medicine and Dentistry, Western University, Trauma Program, London Health Sciences Center, London, Ontario, Canada. Electronic address: kelly.vogt@lhsc.on.ca. 3. Department of Surgery and Medicine, Schulic School of Medicine and Dentistry, Western University, Trauma Program, London Health Sciences Center, London, Ontario, Canada. Electronic address: neil.parry@lhsc.on.ca. 4. Trauma Program, London Health Sciences Center, London, Ontario, Canada. Electronic address: fran.priestap@lhsc.on.ca. 5. Department of Surgery and Medicine, Schulic School of Medicine and Dentistry, Western University, Trauma Program, London Health Sciences Center, London, Ontario, Canada. Electronic address: rob.leeper@lhsc.on.ca. 6. Department of Radiology, Schulic School of Medicine and Dentistry, Western University, London, Ontario, Canada. Electronic address: amol.mujoomdar@lhsc.on.ca. 7. Department of Radiology, Schulic School of Medicine and Dentistry, Western University, London, Ontario, Canada. Electronic address: stewart.kribs@lhsc.on.ca. 8. Department of Medicine and Department of Epidemiology and Biostatistics, London Health Sciences Centre Trauma Program, London, Ontario, Canada. Electronic address: Ian.ball@lhsc.on.ca.
Abstract
OBJECTIVE: To determine if insertion of rIVCF for PE prophylaxis in high risk trauma patients could result in a clinically meaningful reduction (>24 h) in time that patients are left unprotected from PEs SUMMARY AND BACKGROUND DATA: Trauma patients are at high risk for the development of pulmonary embolism (PE). Early pharmacologic PE prophylaxis is ideal, however many patients are unable to receive prophylaxis due to concomitant injuries. Current guidelines are conflicting on the role of prophylactic retrievable inferior vena cava filters (rIVCF) for PE prevention in this patient population, and robust data to guide clinicians is lacking. METHODS: In this single center, randomized control trial of adult (age > 18 years) trauma patients at high risk for PE by EAST criteria and unable to receive pharmacologic prophylaxis for at least 72 h, we randomized 42 patients to receive arIVCF or to not have a rIVCF placed. Our primary endpoints were time left unprotected to PE development and feasibility. RESULTS: The median patient age was 53 years, with a median Injury Severity Score of 33. Randomization to rIVCF reduced the time left unprotected to PE (Control: 78.2 h [53.6-104]; rIVCF: 25.5 h [9.8-44.6], p = 0.0001). Two pulmonary embolisms occurred in the control group, and one in the rIVCF group. Seven deaths occurred in the control group, and 8 in the rIVCF group. CONCLUSION: This feasibility study demonstrates a clinically meaningful reduction in time left unprotected to PE. Further investigations powered to demonstrate a reduction in PE incidence are required. LEVEL OF EVIDENCE: Level 1 Evidence randomized controlled trial.
RCT Entities:
OBJECTIVE: To determine if insertion of rIVCF for PE prophylaxis in high risk traumapatients could result in a clinically meaningful reduction (>24 h) in time that patients are left unprotected from PEs SUMMARY AND BACKGROUND DATA: Traumapatients are at high risk for the development of pulmonary embolism (PE). Early pharmacologic PE prophylaxis is ideal, however many patients are unable to receive prophylaxis due to concomitant injuries. Current guidelines are conflicting on the role of prophylactic retrievable inferior vena cava filters (rIVCF) for PE prevention in this patient population, and robust data to guide clinicians is lacking. METHODS: In this single center, randomized control trial of adult (age > 18 years) traumapatients at high risk for PE by EAST criteria and unable to receive pharmacologic prophylaxis for at least 72 h, we randomized 42 patients to receive a rIVCF or to not have a rIVCF placed. Our primary endpoints were time left unprotected to PE development and feasibility. RESULTS: The median patient age was 53 years, with a median Injury Severity Score of 33. Randomization to rIVCF reduced the time left unprotected to PE (Control: 78.2 h [53.6-104]; rIVCF: 25.5 h [9.8-44.6], p = 0.0001). Two pulmonary embolisms occurred in the control group, and one in the rIVCF group. Seven deaths occurred in the control group, and 8 in the rIVCF group. CONCLUSION: This feasibility study demonstrates a clinically meaningful reduction in time left unprotected to PE. Further investigations powered to demonstrate a reduction in PE incidence are required. LEVEL OF EVIDENCE: Level 1 Evidence randomized controlled trial.