Abstract
Background: Uncontrolled bleeding is a leading cause of death in trauma. Two randomized, placebo-controlled, double-blind trials (one in blunt trauma and one in penetrating trauma) were conducted simultaneously to evaluate the efficacy and safety of recombinant factor VIIa (rFVIIa) as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma. Methodsd: Severely bleeding trauma patients were randomized to rFVIIa (200, 100, and 100 μg/kg) or placebo in addition to standard treatment. The first dose followed transfusion of the eighth red blood cell (RBC) unit, with additional doses 1 and 3 hours later. The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose. Results: Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. In blunt trauma, RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 RBC units, p = 0.02), and the need for massive transfusion (>20 units of RBCs) was reduced (14% vs. 33% of patients; p = 0.03). In penetrating trauma, similar analyses showed trends toward rFVIIa reducing RBC transfusion (estimated reduction of 1.0 RBC units, p = 0.10) and massive transfusion (7% vs. 19%; p = 0.08). Trends toward a reduction in mortality and critical complications were observed. Adverse events including thromboembolic events were evenly distributed between treatment groups. Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in these trauma populations within the investigated dose range.
| Original language | English |
|---|---|
| Pages (from-to) | 8-18 |
| Number of pages | 11 |
| Journal | Journal of Trauma - Injury, Infection and Critical Care |
| Volume | 59 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jul 1 2005 |
| Externally published | Yes |
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Keywords
- Blood transfusion
- Blunt trauma
- Coagulopathy
- Hemorrhage
- Massive transfusion
- Penetrating trauma
- Recombinant factor VIIa
- Trauma
ASJC Scopus subject areas
- Surgery
Cite this
Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients : Two parallel randomized, placebo-controlled, double-blind clinical trials. / Boffard, Kenneth David; Riou, Bruno; Warren, Brian; Choong, Philip Iau Tsau; Rizoli, Sandro; Rossaint, Rolf; Axelsen, Mads; Kluger, Yoram; Champion, Howard R.; Lucas, Charles; Thompson, Errington; Ross, Steve; Jurkovich, Gregory J.; Lynn, Mauricio; Pitts, Lawrence; Croce, Martin A.
In: Journal of Trauma - Injury, Infection and Critical Care, Vol. 59, No. 1, 01.07.2005, p. 8-18.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients
T2 - Two parallel randomized, placebo-controlled, double-blind clinical trials
AU - Boffard, Kenneth David
AU - Riou, Bruno
AU - Warren, Brian
AU - Choong, Philip Iau Tsau
AU - Rizoli, Sandro
AU - Rossaint, Rolf
AU - Axelsen, Mads
AU - Kluger, Yoram
AU - Champion, Howard R.
AU - Lucas, Charles
AU - Thompson, Errington
AU - Ross, Steve
AU - Jurkovich, Gregory J.
AU - Lynn, Mauricio
AU - Pitts, Lawrence
AU - Croce, Martin A.
PY - 2005/7/1
Y1 - 2005/7/1
N2 - Background: Uncontrolled bleeding is a leading cause of death in trauma. Two randomized, placebo-controlled, double-blind trials (one in blunt trauma and one in penetrating trauma) were conducted simultaneously to evaluate the efficacy and safety of recombinant factor VIIa (rFVIIa) as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma. Methodsd: Severely bleeding trauma patients were randomized to rFVIIa (200, 100, and 100 μg/kg) or placebo in addition to standard treatment. The first dose followed transfusion of the eighth red blood cell (RBC) unit, with additional doses 1 and 3 hours later. The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose. Results: Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. In blunt trauma, RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 RBC units, p = 0.02), and the need for massive transfusion (>20 units of RBCs) was reduced (14% vs. 33% of patients; p = 0.03). In penetrating trauma, similar analyses showed trends toward rFVIIa reducing RBC transfusion (estimated reduction of 1.0 RBC units, p = 0.10) and massive transfusion (7% vs. 19%; p = 0.08). Trends toward a reduction in mortality and critical complications were observed. Adverse events including thromboembolic events were evenly distributed between treatment groups. Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in these trauma populations within the investigated dose range.
AB - Background: Uncontrolled bleeding is a leading cause of death in trauma. Two randomized, placebo-controlled, double-blind trials (one in blunt trauma and one in penetrating trauma) were conducted simultaneously to evaluate the efficacy and safety of recombinant factor VIIa (rFVIIa) as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma. Methodsd: Severely bleeding trauma patients were randomized to rFVIIa (200, 100, and 100 μg/kg) or placebo in addition to standard treatment. The first dose followed transfusion of the eighth red blood cell (RBC) unit, with additional doses 1 and 3 hours later. The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose. Results: Among 301 patients randomized, 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis. In blunt trauma, RBC transfusion was significantly reduced with rFVIIa relative to placebo (estimated reduction of 2.6 RBC units, p = 0.02), and the need for massive transfusion (>20 units of RBCs) was reduced (14% vs. 33% of patients; p = 0.03). In penetrating trauma, similar analyses showed trends toward rFVIIa reducing RBC transfusion (estimated reduction of 1.0 RBC units, p = 0.10) and massive transfusion (7% vs. 19%; p = 0.08). Trends toward a reduction in mortality and critical complications were observed. Adverse events including thromboembolic events were evenly distributed between treatment groups. Recombinant FVIIa resulted in a significant reduction in RBC transfusion in severe blunt trauma. Similar trends were observed in penetrating trauma. The safety of rFVIIa was established in these trauma populations within the investigated dose range.
KW - Blood transfusion
KW - Blunt trauma
KW - Coagulopathy
KW - Hemorrhage
KW - Massive transfusion
KW - Penetrating trauma
KW - Recombinant factor VIIa
KW - Trauma
UR - http://www.scopus.com/inward/record.url?scp=24644491444&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=24644491444&partnerID=8YFLogxK
U2 - 10.1097/01.TA.0000171453.37949.B7
DO - 10.1097/01.TA.0000171453.37949.B7
M3 - Article
C2 - 16096533
AN - SCOPUS:24644491444
VL - 59
SP - 8
EP - 18
JO - Journal of Trauma and Acute Care Surgery
JF - Journal of Trauma and Acute Care Surgery
SN - 2163-0755
IS - 1
ER -