Iraqi Experience of Factor VII use in Children

Abstract

Bleeding disorders in pediatrics is an important issue and can be life-threatening if not diagnosed and treated appropriately. We aimed to evaluate Iraqi pediatric practice (as an example of resource-limited settings) about the use of Recombinant Activated Factor VII (RFVIIa) in bleeding disorders, with emphasis on its effectiveness and safety, in comparison with adjuvant therapy.  Budget restrictions may affect the availability of even lifesaving drugs such as (RFVIIa). Therefore, we tried to investigate the local experience of pediatric bleeding, with the evaluation of the potential ability of adjuvant therapy of blood products and vitamin K to substitute RFVIIa in case of non-availability. During a complete one year`s period, 35 patients were recruited prospectively and divided into two categories; study group (on RFVIIa, with or without adjuvant therapy) and control group (only on adjuvant therapy of blood products, and vitamin K), involving 19, and 16 patients, respectively.  The mortality rate in the study group was significantly less than the control group; (36.84%) versus (56.25%). Larger drops in prothrombin time (PT) (42%), and partial thromboplastin time (PTT) (47%), with less multi-organ dysfunction (29%) were noticed with the use of RFVIIa. Septicemia-associated disseminated intravascular coagulation was the most frequent indication of both groups; (31.58%) versus (37.50%), with a significant positive outcome in the study group. Total serum bilirubin levels were found to be lower in all neonates with jaundice within the study group. One patient had venous thrombosis following the RFVIIa administration. In conclusion, RFVIIa has the potential to stop pediatric bleeding episodes significantly better than adjuvant therapy alone, with significantly less mortality. Safety was ensured in all survived cases except one who had thromboembolism. Neonatal jaundice was improved by the use of RFVIIa.