Use of recombinant activated factor VII (rFVIIa) for management of postoperative bleeding in patients with idiopathic thrombocytopenic purpura (ITP)

Abstract number: P1139

Shulutko* E., Gorodetsky† V., Galstyan‡ G.

‡National Rcearch Center for Hematology, Russia †National Recearch Center for Hematology, Russia; *National Research Center for Hematology, Russia;

Present study evaluates feasibility of recombinant activated factor VII (rFVIIa, NovoSeven) to stop postoperative bleeding after splenectomy performed in patients with refractory ITP, complicated with hemorrhagic syndrome. Case #1: a 20-year-old female performed a significant exacerbation of ITP on the 17th week of pregnancy. She was treated with 60–100 mg of methylprednisolon daily; however, by the 30th week of pregnancy platelet count was reported 0–1 × 106 mL^-1 and hemorrhagic syndrome developed. The patient underwent transthoracic splenectomy. Four hours following the surgery bleeding continued. A single dose of 3.6 mg rFVIIa (55 mg kg^-1) was given as an i.v. bolus. Hematologic values pre-rFVIIa infusion are shown in the table. Case #2: a 32-year-old female showed first symptoms of ITP on the 26th week of pregnancy; treated with methylprednisolon (60 mg daily), platelet count 0–1 × 106 mL^-1 and hemorrhagic syndrome by the 29th week of pregnancy. The transthoracic splenectomy was performed. Two doses of 3.6 mg rFVIIa (50 mg kg^-1) were given intravenously with a 2-h interval to control the postoperative bleeding. In both cases bleeding stopped in 15 min following the infusion of rFVIIa. No clinical signs of DIC were reported. Normal condition of the fetus confirmed by cardiotocorgraphy. The platelet count on the 40th week of pregnancy was reported 161 × 106 mL^-1 (in the 1st case) and 302 × 106 mL^-1 (in the 2nd case). In both cases pregnancy resulted in the successful delivery of healthy newborn with a normal platelet count. Case #3: a 24-year-old female with a history of ITP since childhood, received methylprednisolon (60–120 mg daily) during the latest relapse; underwent laparoscopic splenectomy. In 30 min after the surgery two doses of 2.4 mg rFVIIa (41 mg kg^-1) were given with a 4-h interval. The bleeding markedly decreased following the first infusion and stopped after the second. In 24 h PLT increased up to 111 × 106 mL^-1. Our limited experience suggests a potential efficiency of rFVIIa in controlling the postoperative bleeding after splenectomy in patients with ITP.

Table 1.