Evaluation of a haemostatic agent in rabbits.

Topical hemostatic agents are applied locally to areas of injured vascular endothelium to control local bleeding. Ankaferd Blood Stopper (ABS) has gained approval in Turkey and Bosnia-Herzegovina as a topical haemostatic agent for external post-surgical and post-dental surgery bleeding. The safety of topical use of ABS has been demonstrated in numerous in vitro and in vivo animal models, as well as in a clinical Phase I trial in humans. ABS, besides its haemostatic activity, also has in vitro anti-infectious and anti-neoplastic effects. To assess potential detrimental effects of intravenous administration of ABS into intact systemic circulation in a rabbit experimental model, one milliliter of ABS was administered intravenously into the systemic circulation of twelve rabbits which were included in the study via the marginal ear vein. Animals were observed for 1 hr before euthanasia was performed by administering 40 mg of intracardiac suxamethonium chloride. In the event of death (cardiopulmonary arrest) before the end of the planned observation period of 60 minutes, time of death was recorded and histopathological examination of the liver and spleen was commenced. Ten rabbits were alive by the end of the planned observation period, without showing any clear signs of discomfort, whereas two animals died within five minutes after systemic administration of intravenous ABS. Postmortem histopathological examination of the livers and spleens of all animals' revealed findings consistent with hepatic venous outflow obstruction. Systemic intravascular administration of ABS into intact vascular endothelium should never be performed in any setting. Further experimental and clinical studies on this liquid hemostatic agent should proceed by accepting ABS as purely a topical haemostatic agent, to be applied solely to areas of injured vascular endothelium.