It is important to reach intra-operative haemostasis in a little time to prevent blood loss in patients during surgeries.. The regular methods used for this purpose includes sutures, cautery, and ligation. However, in certain cases, the use of these methods may be ineffective or impractical. In such cases an adjunct, such as a fibrin solutions, is needed to achieve hemostasis quickly. Fibrin Solutions, which essentially container fibrinogen and thrombin, have been used effectively for hemostasis in various types of surgeries such as nephrolithotomy, vascular surgeries, nose jobs, and even removing tumor (Chapman, Wren et al. 2002; Schenk, Burks et al. 2003, Shah, Hegde et al.
2006; Chalmers, Darling Iii et al. 2010).The TRM Data shows that the pediatric population in the U.S.
A. receives a broad range of surgical procedures although at a much lower frequency than adults ( (Table 1).Fibrin solutions have been used for a long time on pediatric patients.
A particular application of fibrin solutions in these populations has been to achieve hemostasis during heart surgery. Reports from as early as 1980’s suggest that these can be used with great effect in the pediatric population for the treatment of various congenital heart diseases, including arterial switch operations and complex reconstructions of the pulmonary arteries. A constituent of fibrin solutions, aproptinin, came to be associated with side effects in adults and in children . It has been shown in a pediatric study that if a baby has had previous exposure to aprotinin, a second, third, or even fourth exposure may spawn a systemic immune reaction. These children responded by developing IgE antibody against aprotinin, which if produced in excess can lead to anaphylaxis reaction (Scheule, Beierlein et al. 2012).
Another fibrinolytic agent generally present in thrombin solutions is tranexamic acid (TXA). The recent studies have shown that the TXA can have several side effects, especially when used during heart surgeries (Martin, Wiesner et al. 2008,Murkin, Falter et al. 2010, Martin, Knorr et al. 2011). Fits, brain disorders and kidney dysfunction were the most commonly observed side-effects of TXA (Sander, Spies et al. 2010). Two possible mechanisms have been reported to explain the effect of TXA on the brain.
According to the first, TXA binds to the ?-aminobutyric acid (GABA) The binding site of GABA-receptor, thereby inducing hyper-excitability by blocking GABA-driven inhibition of the central nervous system (Furtmuller, Schlag et al. 2002). Second reported mechanism suggests that TXA significantly reduces the blood flow from the brain (loss of drainage), possibly resulting in a fit-like symptoms (Tsementzis, Meyer et al. 1992; Sander, Spies et al. 2010).Fibrin solutions have been shown to be more efficient than several of the existing haemostatic agents (Madariaga et al.
2004, Stavrou et al. 2o05). However, there is a need for developing Hemostats that are free of aprotinin and TXA and consist of all-human constituents that can be safely used in operations on children without the chance that any immune reactions or adverse nervous system effects will occur. This study is comparing the efficacy and safety of such a fibrin solution ABD32, to a well-established absorbable haemostat SXS4® in a paediatric population. The data show that ABD32is more effective than SXS4® in achieving homeostasis since 100% patients showed haemostasis at the primary point in the ABD32 group as compared to 71.
4% in the SXS4® group. Furthermore, in the ABD32 group, 100% patients achieved complete hemostasis in less than 4 minutes (as compared to 42.9% in the SX4® group), this demonstrates the efficacy of ABD32. There were no complications related to ABD32 and the incidence of side effects and serious adverse effects was lesser to the ABD32 ® group.
The study hue is therefore concluded ABD32 to be more competent in achieving hemostasis and safe as compared to SX4® in small children.