title: The Effect of Intravenous Administration of Active Recombinant Factor VII on Postoperative Bleeding in Cardiac Valve Reoperations; A Randomized Clinical Trial.
abstract: BACKGROUND
  Postoperative bleeding after cardiac reoperations is among the most complicating problems, both for the physicians and for the patients. Many modalities have been used to decrease its adverse effects and the need for blood products administration.
  
  
  OBJECTIVE
  In a randomized double-blinded clinical trial of redo cardiac valve surgery in adult, the effect of active recombinant factor VII (rFVIIa) on postoperative bleeding was compared with placebo. Chest tube drainage was used for comparison of bleeding between the two groups.
  
  
  METHODS
  Two groups of 18 patients undergoing redo valve surgeries were treated and compared regarding chest tube drainage, need for blood products, prothrombin time (PT), partial thromboplastin time (PTT), hemoglobin and hematocrit, platelet count, and international normalized ratio (INR) in first 24 hours after surgery. Bleeding was assessed at 3rd, 12th, and 24th hour after operation. In rFVIIa group, 40 µg/kg of AryoSeven was administered before end of surgery and same volume of normal saline was administered as placebo in the control group.
  
  
  RESULTS
  Study groups showed no difference regarding baseline variables. Three patients in rFVIIa group (16.67%) and 13 in placebo group (72.23%) received blood products (P < 0.01). Chest tube blood drainage at 24th hour after operation was 315 ± 177 mL in rFVIIa group and 557 ± 168 mL in control group (P = 0.03). At third and 12th hour after operation, the difference was not statistically significant (P = 0.71 and P = 0.22, respectively). Postoperative ICU stay was not different; while extubation was longer in the placebo group (352 ± 57 vs. 287 ± 46 minutes; P = 0.003).
  
  
  CONCLUSIONS
  Our study demonstrated the efficacy of rFVIIa in controlling postoperative bleeding in redo cardiac valve surgeries regarding subsequent blood loss and transfusion requirement; however, outcome results remains to be defined.
authors: Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors: Narges
authors: N
authors: Payani
authors: Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors: Mahnoosh
authors: M
authors: Foroughi
authors: Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors: Ali
authors: A
authors: Dabbagh
keywords: Activated Recombinant Factor VII; Cardiac Surgical Procedure; Postoperative Hemorrhage; Reoperation