Lodge, J.P.A., Jonas, S., Oussoultzoglou, E., Malagó, M., Jayr, C., Cherqui, D., . . . Mimoz, O. (2005). Recombinant coagulation factor VIIa in major liver resection: A randomized, placebo-controlled, double-blind clinical trial. Anesthesiology, 102, 269–275.

DOI Link

Intervention Characteristics/Basic Study Process

Placebo versus two treatment arms of recombinant coagulation factor VIIa: 20 mcg/kg and 80 mcg/kg

Sample Characteristics

  • N = 204
  • OTHER KEY SAMPLE CHARACTERISTICS: Noncirrhotic adults undergoing partial hepatectomy for cancer and/or benign tumors



 

Study Design

  • Placebo-controlled RCT

Measurement Instruments/Methods

  • Designed for 50% relative reduction
  • Outcome measures included erythrocyte transfusion during or 48 hours after surgery
  • Amount of erythrocytes transfused
  • Change in hematocrit
  • Requirement of fresh frozen plasma
  • Surgery time
     

Results

Perioperative transfusion difference approached significance (P = 0.09). Mean requirements decreased with rFVIIa (P = 0.78). Blood loss during surgery decreased (P = 0.07).





 

Limitations

  • 80% power
  • Significance level 5%
  • Exceeded 180 sample size
  • No statistically significant results
  • Larger trial needed for better evaluation

Nursing Implications

A larger trial is needed for better evaluation.