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.Objectives: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.Patients and 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.

Comparison of low- and high-dose recombinant activated factor VII for postcardiac surgical bleeding

“…Payani et al . [ 20 ] in a randomized clinical trial studied the effect of prophylactic use of low dose 40 mcg/kg rFVII on patients undergoing redo valve surgeries. They concluded that 40 mcg/kg of rFVII could be effective in reducing the volume of postoperative chest tube drainage and need for blood transfusion, with no thromboembolic event.…”

A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial of High-Dose, Short-Term Vitamin D Administration in the Prevention of Acute Kidney Injury after Cardiac Surgery

“…For both groups, the coronary artery bypass was performed in the culprit lesions by a surgical team. All patients were treated according to a fixed protocol for general anesthesia, surgical, hemodynamic, and CPB management, which has already been described in detail [18]. Mean arterial pressure was maintained on 60–80 mm Hg, and deviations were corrected with nitroglycerin and phenylephrine (after optimization of preload, CVP ≥10 cm H 2 O).…”

Off-label Use of Recombinant Activated Factor VII for Cardiac Surgical Bleeding

“…Importantly, only 4 of the 29 studies involved cardiac surgical patients (four of the five randomized adult cardiac surgical studies were cited 35,36,38,39 ; the fifth was yet to be published). 37 Despite this small subset of cardiac surgical patients, the authors still advised that the “effectiveness of recombinant activated factor VII as a more general hemostatic drug, either prophylactically or therapeutically, remains unproven. The use recombinant activated factor VII outside its current licensed indications should be restricted to clinical trials.”…”