Use of recombinant activated factor VII (rFVIIa-NovoSeven) in the treatment of uncontrolled postsurgical hemorrhage in a patient with deep venous thrombosis and caval filter. A case report.

A 37-year-old woman affected by renal insufficiency was submitted to renal transplantation from cadaver donor. After a few days she had a severe and life-threatening hemorrhage at the surgical site and a deep venous thrombosis at her lower right limb. Since anticoagulant therapy was contraindicated, a filter was inserted in the inferior vena cava. After several red blood cell, fresh plasma and platelet transfusions, and after repeated unsuccessful surgical procedures, a single dose of 70 microg/kg of body weight of recombinant activated factor VII (rFVIIa) was administered as last resource. The drug was successful in obtaining the complete and rapid resolution of the hemorrhagic episode. Despite the patient had two factors which could have favoured a thrombotic complication, e.g. deep venous thrombosis and caval filter, administration of rFVIIa did not worsen the underlying thrombotic process. rFVIIa is a new hemostatic agent that was initially used in hemophiliac patients. Later it has been successfully used in nonhemophiliac patients to treat different inherited or acquired coagulation disorders. A potential thrombogenic effect of rFVIIa was hypothesized on the basis of some clinical case reports but large controlled trials do not exist. In this case report the use of rFVIIa was successful and safe despite the concomitant presence of several thrombogenic factors.

Postoperative sedation with propofol infusion: haemodynamics and pharmacokinetics.

OBJECTIVE: This study was designed to investigate the haemodynamic response and pharmacokinetics of a low-dose propofol continuous infusion in providing sedation in patients who required mechanical ventilation after coronary artery bypass grafting surgery. PATIENTS: 22 male patients, aged between 45 and 65 years, were evaluated in an open, uncontrolled study. INTERVENTIONS: At the end of the surgical procedure, a low-dose (1 mg/kg/h) propofol infusion was started and adjusted to optimise sedation according to the Ramsay scale. The mean propofol infusion rate was 1.42 +/- 0.4 mg/kg/h. MAIN OUTCOME MEASURES: Electrocardiogram, systemic and pulmonary arterial pressure, and central venous pressure were monitored continuously. Left ventricular shortening fraction was calculated by transoesophageal echocardiography. Propofol plasma levels were calculated in 10 patients to evaluate the pharmacokinetics. RESULTS: Throughout the duration of the study all patients were haemodynamically stable. Sedation was maintained for 363 +/- 244 minutes and was adequate in all patients. The clinical recovery time (postsedation responsiveness) was 15.7 +/- 6.2 minutes, after infusion suspension. There was no correlation between propofol plasma levels or propofol infusion rate and the depth of sedation (respectively, r = 0.39 and r = 0.23), while there was a good correlation (r = 0.62) between propofol infusion rate and plasma levels. Open two-compartment model pharmacokinetics were demonstrated. CONCLUSION: Low-dose propofol infusion (1 to 2 mg/kg/h) proved to be well tolerated and effective in maintaining sedation after cardiac surgery. Sedation was quickly obtained without a propofol loading dose; steady-state plasma concentrations of 0.6 to 0.8 mg/L were rapidly achieved. Propofol pharmacokinetics ensure rapid clearance with rapid clinical recovery.