Abstract

BACKGROUND Traumatic brain injury (TBI) is a general and socioeconomic complication and is one of the important causes of mortality and disability among young people in the world. Falling and violence and sports injuries are the other cause. It causes for about ten million new patients, accounting for 9% of all deaths. This interventional study aims to investigate the effects of early administration of cryoprecipitate to prevent expansion of intracranial hemorrhage. METHODS This randomized clinical trial recruited 54 non-pregnant patients. 27 patients in the control group and 27patients in the interventional group. For all patients, common and accepted procedures in scientific centers, including anticonvulsant drugs, normal saline and the other routine management was done and only for patients in the intervention group, 4 units of cryoprecipitate were added to their routine treatments; computed tomography scan (CT) scan was performed 48 hours later in both groups and finally the contusion size was compared in both groups. RESULTS It was observed in the intervention group that by adding 4 units of cryoprecipitate to their treatments; they had no increased size of the brain parenchymal contusion according to the criteria defined in the study compared to the control group (OR: 0.08, 95% CI: 0.0102_0.6303). CONCLUSIONS According to a clinical trial, it seems that cryoprecipitate can prevent of cerebral parenchymal hemorrhage expansion in traumatic patients.

Abstract

INTRODUCTION This study compared the efficacy of Aryoseven with Novoseven to control bleeding episodes in patients with hemophilia A with inhibitors. METHODS Sixty-six patients were randomized into 2 groups, with 4 consecutive block randomization. These groups received Aryoseven and Novoseven dosages of 90 to 120 mug/kg intravenously every 2 hours. RESULTS Median (interquartile range) level of factor VIII (FVIII) inhibitor in groups A and B was 15.0 and 19.0 Bethesda Unit (BU) preadministration. Bleeding onset in group A was 1246 +/- 1104 minutes and in group B was 2301 +/- 1693 minutes (P = .311). The Kavakli global response scores and treatment success rate was comparable in both the groups. The side effects in groups A (9.7%) and B (2.9%) were comparable. CONCLUSION Biosimilar recombinant activated FVII is found to be as effective as Novoseven in the treatment of acute joint bleeding in patients with hemophilia with inhibitors. Its usage will decrease the gaps in hemophilia.Copyright © The Author(s) 2014.

Abstract

In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 mug/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVIIcoagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy. Copyright © The Author(s) 2014.