The role of recombinant-activated factor VII in bleeding trauma patients

Dutton, Richard P.; Conti, Bianca

doi:10.1097/aco.0b013e32832678c6

Cited by 11 publications

(6 citation statements)

References 41 publications

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“…Several animal studies and smaller clinical trials of this procoagulant therapy have been published in the past decade. 47 However, these studies do not challenge fluid therapy and, therefore, are outside the scope of this review.…”

Section: Hemostatic Dressings and Drugsmentioning

confidence: 99%

Fluid therapy in uncontrolled hemorrhage – what experimental models have taught us

Hahn

2012

Acta Anaesthesiol Scand

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Intravenous fluid is life-saving in hypovolemic shock, but fluid sometimes aggravates the bleeding. During the past 25 years, animal models have helped our understanding of the mechanisms involved in this unexpected effect. A key issue is that vasoconstriction is insufficient to arrest the bleeding when damage is made to a major blood vessel. ‘Uncontrolled hemorrhage’ is rather stopped by a blood clot formed at the outside surface of the vessel, and the immature clot is sensitive to mechanical and chemical interactions. The mortality increases if rebleeding occurs. In the aortic tear model in swine, hemorrhage volume and the mortality increase from effective restoration of the arterial pressure. The mortality vs. amount of fluid curve is U-shaped with higher mortality at either end. Without any fluid at all, irreversible shock causes death provided the hemorrhage is sufficiently large. Crystalloid fluid administered in a 3 : 1 proportion to the amount of lost blood initiates serious rebleeding. Hypertonic saline 7.5% in 6% dextran 70 (HSD) also provokes rebleeding resulting in higher mortality in the recommended dosage of 4 ml/kg. Uncontrolled hemorrhage models in rats, except for the ‘cut-tail’ model, confirm the results from swine. To avoid rebleeding, fluid programs should not aim to fully restore the arterial pressure, blood flow rates, or blood volume. For a hemorrhage of 1000 ml, computer simulations show that deliberate hypovolemia (−300 ml) would be achieved by infusing 600–750 ml crystalloid fluid over 20–30 min or 100 ml of HSD over 10–20 min in an adult male

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Section: Hemostatic Dressings and Drugsmentioning

confidence: 99%

Fluid therapy in uncontrolled hemorrhage – what experimental models have taught us

Hahn

2012

Acta Anaesthesiol Scand

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“…A common ''standard dose'' for offlabel use is 90 lg/kgBW [73,82]. A repetitive dose may be needed within 30 min-2 h, although repeat dosing is more likely to indicate futility than to be effective [82]. A repetitive dose may be needed within 30 min-2 h, although repeat dosing is more likely to indicate futility than to be effective [82].…”

Section: Recombinant Activated Factor VIImentioning

confidence: 99%

Coagulation management in multiple trauma: a systematic review

et al. 2011

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“…However, there is conflicting evidence in the literature on the use of the drug outside approved indications 16,17. Retrospective reports of a small number of cases suggest beneficial effects of the drug in controlling bleeding, reducing transfusion of blood products and improving survival 17,18. Two parallel, randomized, placebo‐controlled, double‐blind clinical trials, performed simultaneously to evaluate the safety and efficacy of rFVIIa as an adjunct to control hemorrhage in trauma, demonstrated a significant reduction in RBC transfusion in blunt trauma 19.…”

Section: Introductionmentioning

confidence: 99%

Recombinant factor VIIA is associated with an improved 24-hour survival without an improvement in inpatient survival in massively transfused civilian trauma patients

Nascimento

Lin

Callum

et al. 2011

Clinics

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OBJECTIVE:To determine whether recombinant factor VIIa (rFVIIa) is associated with increased survival and/or thromboembolic complications.INTRODUCTION:Uncontrollable hemorrhage is the main cause of early mortality in trauma. rFVIIa has been suggested for the management of refractory hemorrhage. However, there is conflicting evidence about the survival benefit of rFVIIa in trauma. Furthermore, recent reports have raised concerns about increased thromboembolic events with rFVIIa use.METHODS:Consecutive massively transfused (≥ 8 units of red blood cells within 12 h) trauma patients were studied. Data on demographics, injury severity scores, baseline laboratory values and use of rFVIIa were collected. Rate of transfusion in the first 6 h was used as surrogate for bleeding. Study outcomes included 24‐hour and in‐hospital survival, and thromboembolic events. A multivariable logistic regression analysis was used to determine the impact of rFVIIa on 24‐hour and in‐hospital survival.RESULTS:Three‐hundred and twenty‐eight patients were massively transfused. Of these, 72 patients received rFVIIa. As expected, patients administered rFVIIa had a greater degree of shock than the non‐rFVIIa group. Using logistic regression to adjust for predictors of death in the regression analysis, rFVIIa was a significant predictor of 24‐hour survival (odds ratio (OR) = 2.65; confidence interval 1.26–5.59; p = 0.01) but not of in‐hospital survival (OR = 1.63; confidence interval 0.79–3.37; p = 0.19). No differences were seen in clinically relevant thromboembolic events.CONCLUSIONS:Despite being associated with improved 24‐hour survival, rFVIIa is not associated with a late survival to discharge in massively transfused civilian trauma patients.

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The role of recombinant-activated factor VII in bleeding trauma patients

Abstract: We present a brief discussion of the mechanism of action of rFVIIa and its role in facilitating hemostasis and a review of the recent medical literature on the use of rFVIIa in trauma patients, including current guidelines and controversies.

Cited by 11 publications

References 41 publications

Fluid therapy in uncontrolled hemorrhage – what experimental models have taught us

Fluid therapy in uncontrolled hemorrhage – what experimental models have taught us

Coagulation management in multiple trauma: a systematic review

Recombinant factor VIIA is associated with an improved 24-hour survival without an improvement in inpatient survival in massively transfused civilian trauma patients

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