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.

Endoscopic topical application of Ankaferd Blood Stopper for neoplastic gastrointestinal bleeding: A retrospective analysis.

AIM: The aim of this study was to retrospectively assess the haemostatic efficacy of the endoscopic topical use of Ankaferd Blood Stopper (ABS) in the setting of neoplastic GI bleeding. METHODS: The records of 10 patients with neoplastic GI bleeding (7 gastric, 3 rectal) were evaluated retrospectively. Written informed consent regarding the off-label use of ABS as a means of attaining haemostasis had been obtained from all of the patients prior to the procedure. In all patients, ABS was applied topically. Rates of bleeding control and post-procedural complications were documented. RESULTS: Haemostasis was achieved in all patients within seconds of endoscopic application of ABS, with no immediate complications. Seven patients underwent subsequent cancer surgery after a bleeding-free post-procedural period. CONCLUSIONS: ABS as a novel haemostatic agent could have a potential benefit in controlling bleeding from GI tumours. Prospective controlled studies are needed to help establish its efficacy, and perhaps offer a comparison to conventional haemostatic interventions.

Oral systemic administration of Ankaferd blood stopper has no short-term toxicity in an in vivo rabbit experimental model.

BACKGROUND: Ankaferd blood stopper (ABS) is a standardized herbal extract obtained from 5 different plants. In Turkey, it has been approved for local topical applications in external postsurgical and postdental surgery bleedings. Ankaferd blood stopper, besides its hemostatic activity, has in vitro anti-infectious and antineoplastic actions. OBJECTIVE: The aim of this study was to assess short-term hematological and biochemical safety following the oral systemic administration of ABS to rabbits. METHODS: Twelve rabbits (aged 6-12 months) were included to test the safety of oral ABS. Animals were divided into 4 groups, which had ABS administered orally at doses of 1, 3, 6, and 9 mL, irrespective of their weight. The general well-being and feeding patterns of the animals were observed for a period of 7 days. Blood samples (5.5 mL) were obtained just before oral administration, on days 1 and 4. RESULTS: During the observation period of 7 days, none of the animals showed any abnormal behavior or deviation from the normal. Acute mucosal toxicity, hematotoxicity, hepatotoxicity, nephrotoxicity, and biochemical toxicity were not observed during the short-term follow-up of the animals. CONCLUSIONS: No signs of toxicity were observed in rabbits during short-term study with oral ABS administration.

Hemostatic efficacy of Ankaferd Blood Stopper in a swine bleeding model.

OBJECTIVE: The purpose of this study was to show the hemostatic effect of spray, solution and tampon forms of Ankaferd Blood Stopper (ABS), a unique medicinal plant extract historically used as a hemostatic agent in Turkish folklore medicine, in a porcine bleeding model. MATERIALS AND METHODS: Two 1-year-old pigs were used as bleeding models for superficial and deep skin lacerations, grade II liver and spleen injuries, grade II saphenous vein injury and grade IV saphenous artery injury. Spray, solution or tampon forms of ABS were applied after continuing bleeding was confirmed. The primary outcome was time to hemostasis. Volume of blood loss was not measured. The pigs were euthanized at the end of the experiment. RESULTS: Spray or direct application of ABS solution resulted in instant control of bleeding in superficial and deep skin lacerations as well as puncture wounds of the liver. A 40-second application of ABS tampon was sufficient to stop bleeding of skin lacerations, while 1.5- and 3.5-min applications were used to control hemorrhage from the saphenous vein and artery, respectively. No rebleeding was observed once hemostasis was achieved. However, repeated applications of ABS solution and tampon were only temporarily effective in the hemostasis of spleen injury. CONCLUSIONS: The data showed that ABS was an effective hemostatic agent for superficial and deep skin lacerations and minor/moderate trauma injuries in a porcine bleeding model.

No alteration in the PFA-100 in vitro bleeding time induced by the Ginkgo biloba special extract, EGb 761, in elderly patients with mild cognitive impairment.

EGb 761 is widely used in the management of mild cognitive impairment in the elderly population. Elucidation of the effects of EGb 761 on primary haemostasis via PFA-100 could represent an important step for better understanding of the haemostatic safety of EGb 761. The purpose of this prospective study is to assess the effects of Ginkgo biloba special extract, EGb 761, on PFA-100 in vitro bleeding time in elderly patients with mild cognitive impairment. A total of 40 elderly patients aged 65-79 years who were referred for geriatric assessment and who were diagnosed as having mild cognitive impairment were included. Patients were started on 80 mg EGb-761 three times daily. The complete set of PFA-100 in vitro bleeding time and coagulation parameters including prothrombin time, activated partial thromboplastin time and International Normalized Ratio were assessed before and on the seventh day of treatment with EGb 761. There was no statistically significant prolongation in PFA-100 in vitro bleeding time or coagulation parameters in patients receiving EGb 761 after 7 days. The data about the safety of EGb 761 from the point of primary haemostasis in our elderly patient population with mild cognitive impairment casts hope for the future management of this 'difficult-to-treat' population with the promising Ginkgo extracts.