Pilot randomized trial of pre-hospital advanced therapies for the control of hemorrhage (PATCH) using pelvic binders

Published:January 04, 2021DOI:



      Pelvic fractures represent a small percent of all skeletal injuries but are associated with significant morbidity and mortality secondary to hemodynamic instability from bleeding bone surfaces and disrupted pelvic vasculature. Stabilization of the pelvis prior to arrival at a treatment facility may mitigate the hemodynamic consequences of pelvic ring injuries and improve morbidity and mortality. Whether pelvic compression devices such as pelvic binders or sheets can be safely applied in the prehospital setting has not been well-studied. This study aims to evaluate the safety of applying a pelvic binder to at-risk patients in the field after scalable training and the feasibility of conducting a randomized trial evaluating this practice in the prehospital setting.


      A pilot study (prospective randomized trial design) was conducted in the pre-hospital environment in an urban area surrounding a level-one trauma center. Pre-hospital emergency medical (EMS) personnel were trained to identify patients at high-risk for pelvic fracture and properly apply a commercial pelvic binder. Adult patients with a high-energy mechanism, suspected pelvic fracture, and “Priority 1” criteria were prospectively identified by paramedics and randomized to pelvic binder placement or usual care. Medical records were reviewed for safety outcomes. Secondary outcomes were parameters of efficacy including interventions needed to control hemorrhage (such as angioembolization and surgical control of bleeding) and mortality.


      Forty-three patients were randomized to treatment (binder: N=20; nonbinder: N=23). No complications of binder placement were identified. Eight patients (40%) had binders placed correctly at the level of the greater trochanter. Two binders (10%) were placed too proximally and 10 (50%) binders were not visualized on x-ray. Two binder group patients and three nonbinder group patients required angioembolization. None required surgical control of pelvic bleeding. Two nonbinder group patients and one binder group patient were readmitted within 30 days and one nonbinder group patient died within 30 days.


      Identification of pelvic fractures in the field remains a challenge. However, a scalable training model for appropriate binder placement was successful without secondary injury to patients. The model for conducting prospective, randomized trials in the prehospital setting was successful.


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        • Grimm M.
        • Vrahas M.
        • Thomas K.
        Pressure-volume characteristics of the intact and disrupted pelvic retroperitoneum.
        J Trauma. 1998; 44: 454-459
        • Schulman J.
        • O'Toole R.
        • Castillo R.
        • Manson T.
        • Sciadini M.
        • Whitney A.
        • et al.
        Pelvic ring fractures are an independent risk factor for death after blunt trauma.
        J Trauma. 2010; 68: 930-934
        • Looser K.
        • Crombie H.
        Pelvic fractures: an anatomic guide to severity of injury. Review of 100 cases.
        AJS. 1976; 132: 638-642
        • Dalal S.
        • Burgess A.
        • Siegel J.
        • Young J.
        • Brumback R.
        • Poka A.
        • et al.
        Pelvic fracture in multiple trauma: classification by mechanism is key to pattern of organ injury, resuscitative requirements, and outcome.
        J Trauma. 1989; 29: 981-1000
        • Verbeek D.
        • Sugrue M.
        • Balogh Z.
        • Cass D.
        • Civil I.
        • Harris I.
        • et al.
        Acute management of hemodynamically unstable pelvic trauma patients: time for a change? Multicenter review of recent practice.
        World J Surg. 2008; 32: 1874-1882
        • Cothren C.
        • Osborn P.
        • Moore E.
        • Morgan S.
        • Johnson J.
        • Smith W.
        Preperitonal pelvic packing for hemodynamically unstable pelvic fractures: A paradigm shift.
        J Trauma. 2007; 62: 839-842
        • Bozeman M.
        • Cannon R.
        • Trombold J.
        • Smith J.
        • Franklin G.
        • Miller F.
        • et al.
        Use of computed tomography findings and contrast extravasation in predicting the need for embolization with pelvic fractures.
        Am Surg. 2012; 78: 825-830
        • Holstein J.
        • Culemann U.
        • Pohlemann T.
        Working Group Mortality in Pelvic Fracture Patients. What are predictors of mortality in patients with pelvic fractures?.
        Clin Orthop Rel Res. 2012; 470: 825-830
        • Gabbe B.
        • de Steiger R.
        • Esser M.
        • Bucknill A.
        • Russ M.
        • Cameron P.
        Predictors of mortality following severe pelvic ring fracture: Results of a population-based study.
        Injury. 2011; 42: 985-991
        • Sathy A.
        • Starr A.
        • Smith W.
        • Elliott A.M.
        • Aqudelo J.
        • Reinert C.
        • et al.
        The effect of pelvic fracture on mortality after trauma: an analysis of 63,000 trauma patients.
        J Bone Joint Surg Am. 2009; 91: 2803-2810
        • Cullinane D.
        • Schiller J.
        • Zielinski M.
        • Bilaniuk J.
        • Collier B.
        • Como J.
        • et al.
        Eastern Association for the Surgery of Trauma practice management guidelines for hemorrhage in pelvic fracture--update and systematic review.
        J Trauma. 2011; 71: 1850-1868
        • White C.
        • Hsu J.
        • Holcomb J.
        Hemodynamically unstable pelvic fractures.
        Injury. 2009; 40: 1023-1030
        • ATLS Subcommittee
        American College of Surgeons' Committee on Trauma, International ATLS working group. Advanced trauma life support (ATLS): The ninth edition.
        J Trauma Acute Care Surg. 2013; 74: 1363-1366
        • Schaller T.
        • Sims S.
        • Maxian T.
        Skin breakdown following circumferential pelvic antishock sheeting: A case report.
        J Orthop Trauma. 2005; 19: 661-665
        • Holcomb J.B.
        • Weiskopf R.
        • Champion H.
        • Gould S.A.
        • Sauer R.M.
        • Brasel K.
        • et al.
        Challenges to effective research in acute trauma resuscitation: Consent and endpoints.
        Shock (Augusta, Ga). 2011; 35: 107-113
        • Salzman J.G.
        • Frascone R.J.
        • Burkhart N.
        • Holcomb R.
        • Wewerka S.S.
        • Swor R.A.
        • et al.
        The association of health status and providing consent to continued participation in an out-of-hospital cardiac arrest trial performed under exception from informed consent.
        Acad Emerg Med. 2015; 22: 347-353
        • Harvin J.A.
        • Podbielski J.M.
        • Vincent L.E.
        • Liang M.K.
        • Kao L.S.
        • Wade C.E.
        • et al.
        Impact of social media on community consultation in exception from informed consent clinical trials.
        J Surg Res. 2019; 234: 65-71
      1. Title 21 Part 50 Protection of Human Subjects.

        • Bonner T.
        • Eardley W.
        • Newell N.
        • Masouros S.
        • Matthews J.
        • Gibb I.
        • et al.
        Accurate placement of a pelvic binder improves reduction of unstable fractures of the pelvic ring.
        J Bone Joint Surg Br. 2011; 93: 1524-1528
        • Harris P.
        • Taylor R.
        • Thielke R.
        • Payne J.
        • Gonzalez N.
        • Conde J.
        Research electronic data capture (REDCap) -- A metadata-driven methodology and workflow process for providing translational research informatics support.
        J Biomed Inform. 2009 Apr; 42: 377-381
        • Knops S.
        • van Riel M.
        • Goosens R.
        • Van Lieshout E.
        • Patka P.
        • Schipper I.
        Measurements of the exerted pressure by pelvic circumferential compression devices.
        Open Orthop J. 2010; 4: 101-106
        • Jowett A.
        • Bowyer G.
        Pressure characteristics of pelvic binders.
        Injury. 2007; 38: 118-121
        • Bottlang M.
        • Simpson T.
        • Sigg J.
        • Krieg J.
        • Madey S.
        • Long W.
        Noninvasive reduction of open-book pelvic fractures by circumferential compression.
        J Orthop Trauma. 2002; 16: 367-373
        • Hedrick-Thompson J.
        A review of pressure reduction device studies.
        J Vasc Nurs. 1992; 10: 3-5
        • Knops S.P.
        • EMM Van Lieshout
        • Spanjersberg W.R.
        • Patka P.
        • Schipper I.B.
        Randomised clinical trial comparing pressure characteristics of pelvic circumferential compression devices in healthy volunteers.
        Injury. 2011; 42: 1020-1026
        • Tile M.
        • Pennal G.
        Pelvic disruption: principles of management.
        Clin Orthop Rel Res. 1980; 151: 56-64
        • Bottlang M.
        • Krieg J.
        • Mohr M.
        • Simpson T.
        • Madey S.
        Emergent management of pelvic ring fractures with use of circumferential compression.
        J Bone Joint Surg. 2002; 84: 43-47
        • Ghaemmaghami V.
        • Sperry J.
        • Gunst F.R.
        • Starr A.
        • Frankel H.
        • Gentilello L.
        • et al.
        Effects of early use of external pelvic compression on transfusion requirements and mortality in pelvic fractures.
        Am J Surg. 2007; 194: 720-723
        • Prasarn M.
        • Small J.
        • Conrad B.
        • Horodyski N.
        • Horodyski M.
        • Rechtine G.
        Does application position of the T-POD affect stability of pelvic fractures?.
        J Orthop Trauma. 2013; 27: 262-266
        • Aksu N.
        • Karaca S.
        • Kara A.
        • Işiklar Z.
        Minimally invasive plate osteosynthesis (MIPO) in diaphyseal humerus and proximal humerus fractures.
        Acta Orthop Traumatol Turc. 2012; 46: 154-160
        • Croce M.
        • Magnotti L.
        • Savage S.
        • Wood G.
        • Fabian T.
        Emergent pelvic fixation in patients with exsanguinating pelvic fractures.
        J Am Coll Surg. 2007; 204 (discussion40–2): 935-939