Get access

The treatment of bleeding is to stop the bleeding! Treatment of trauma-related hemorrhage

Authors

  • Kenneth D. Boffard,

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author
  • Philip Iau Tsau Choong,

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author
  • Yoram Kluger,

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author
  • Bruno Riou,

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author
  • Sandro B. Rizoli,

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author
  • Rolf Rossaint,

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author
  • Brian Warren

    1. From the Department of Surgery, Johannesburg Hospital, University of Witwatersrand, Johannesburg, South Africa; Department of Surgery, National University Hospital, Singapore; Trauma Department, Rambam Hospital, Haifa, Israel; Department of Emergency Medicine and Surgery and Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France; Sunnybrook Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Anesthesiology, University Clinics, Aachen, Germany; and the Department of Surgery, Tygerberg Hospital, University of Stellenbosch, Tygerberg, South Africa.
    Search for more papers by this author

Kenneth D. Boffard, Johannesburg Hospital Trauma Unit, University of Witwatersrand, PostNet Suite 235, Private Bag X2600, Houghton, Johannesburg 2041, South Africa; e-mail: kdboffard@pixie.co.za.

Abstract

BACKGROUND: The secret with any alternative to transfusion is to minimize the need for transfusion in the first place. This can be done by reducing the volume of blood loss. The volume of blood being lost can be reduced by direct methods where possible (i.e., hemostasis at the point of bleeding), or by improving the coagulation profile of the patient, thereby improving the extrinsic coagulation. Recombinant activated factor VII (rFVIIa) offers theoretical possibilities of improving the coagulation profile.

STUDY DESIGN AND METHODS: The efficacy and safety of rFVIIa for the treatment of bleeding in patients with severe blunt and penetrating trauma has been investigated in two double-blind, placebo-controlled studies within a single trial—one on patients with blunt injury and the other in similar patients with penetrating injury.

RESULTS: In patients with blunt trauma alive at 48 hours, treatment with rFVIIa effected a significant reduction in the primary endpoint of 48-hour red blood cell (RBC) transfusion requirement (p = 0.02), and the safety of the dosing regimen was established. Similar trends were observed in patients with penetrating injuries. Across both studies and treatment arms, the 48-hour mortality rate ranged from 16 to 19 percent. In the blunt trauma study, this equated to 13 patients from each arm who died before the benefits of treatment could be adequately assessed. Analysis of data for the 117 blunt trauma patients who survived at least 48 hours after receiving study treatment shows that, in addition to reducing RBC requirement, rFVIIa significantly reduced the need for massive transfusion over 48 hours (>20 RBC units) (relative risk reduction of 56% [95% confidence interval: 9%-79%]; p = 0.03), and the fresh-frozen plasma (p = 0.036), platelet (p = 0.023), and cryoprecipitate (p = 0.053) requirements within 48 hours, and was associated with a significant reduction in the 30-day risk of acute respiratory distress syndrome (ARDS) (p = 0.05) and multiple organ failure and/or ARDS (p = 0.05).

CONCLUSION: Treatment with adjunctive rFVIIa significantly reduces transfusion requirements in the 48 hours after severe injury and these procoagulant effects may improve clinical outcome at 30 days.

Ancillary