Recombinant activated factor VII in patients with cancer and hemorrhagic disseminated intravascular coagulation

Abstract

Hemorrhagic disseminated intravascular coagulation (DIC) associated with the presence of underlying advanced or metastatic tumors are often difficult to control by conventional methods. We report the use of recombinant activated factor VII (rFVIIa) in patients with cancer and bleeding secondary to DIC. A total of 18 patients with cancer met pre-defined criteria for DIC. All patients had failed to respond to transfusion with blood products and treatment of the underlying malignancy prior to the introduction of rFVIIa. The median laboratory data at the time of treatment with rFVIIa were as follows: hemoglobin, 7.7 g/dl; platelets, 54 x 10(9)/l; prothrombin time, 21 s; activated partial thromboplastin time, 41 s fibrinogen, 83 mg/dl; D-dimer, 17 microg/ml; and antithrombin, 32%. The dose of rFVIIa was 90 microg/kg and the median number of doses administered was 5 (range, 3-10). Serial measurements of coagulation parameters were obtained at frequent intervals during treatment with rFVIIa. Of the 18 patients, 15 responded with cessation of bleeding and improvement in coagulation data. The prothrombin time and activated partial thromboplastin time normalized in all responding patients within 24 h of treatment. The median fibrinogen was 214 mg/dl while the median D-dimer was 6 microg/dl at 48 h following the administration of rFVIIa. No thromboembolic complications were observed following rFVIIa. Our data provide evidence that rFVIIa can be used successfully to control the hemorrhagic episodes associated with DIC. Although this type of treatment appears to be safe, close monitoring of the patients is warranted.

Administration of Recombinant Activated Factor VII (NovoSeven) in Three Cases of Uncontrolled Bleeding Caused by Disseminated Intravascular Coagulopathy

“…Our approach of administering rFVIIa to counteract massive bleeding related to DIC is confirmed by a series of 18 nonsurgical patients with advanced or metastatic cancers, and bleeding secondary to DIC. Fifteen responded with cessation of bleeding, and no thromboembolic complications were observed (17). In addition, 2 other case reports confirm our results.…”

Whole blood coagulation in children with thrombocytopenia and the response to platelet replacement, recombinant factor VIIa, and a potent factor VIIa analogue

“…rFVIIa has been reported as a potential pharmacological candidate to support haemostasis during thrombocytopenia (Kristensen et al, 1996;Kjalke et al, 2001). Various publications have reported on the successful use of rFVIIa in treatment of bleeding during thrombocytopenia, but variable results have still been reported from clinics (Kristensen et al, 1996;Gerotziafas et al, 2002;Sallah et al, 2004;Brenner et al, 2005;Pihusch et al, 2005).…”

Thrombocytopenia and thrombosis in disseminated intravascular coagulation (DIC)

“…In order to work, thrombin must be able to be generated so might be resistant to all other efforts expected to not work in massive heparin overdosage or in situations having no fibrinogen and/or platelets. Several small case series [17][18][19] suggest possible efficacy in patients with DIC.…”