Fibrin sealant agents: clinical application of TachoSil® in abdominal surgery. Six years experience in an emergency surgery department and review of the literature.

BACKGROUND: The success of every surgical procedure depends on an appropriate hemostatis. Topical haemostatic agents, like fibrin sealants, are an option for providing haemostasis and may be particularly useful for complex injuries. AIM: The aim of the study is to evaluate the use of TachoSil® in abdominal surgery and its benefits to prevent bleedings, and to establish its fields of use. METHODS: A retrospective observational study was performed on 308 patients underwent to emergency surgery with TachoSil®'s application into our department between January 2012 and March 2018. RESULTS: After the application of the hemostatic device there have been no haemorrhagic complications that have needed a second surgical intervention. Most frequently use of TachoSil® was in the gallbladder bed after cholecystectomy for an acute cholecystitis. CONCLUSIONS: Our experience, supported by other reports in the literature, suggests the use of TachoSil® may provide an effective option in helping to control bleedings.

[Topical haemostatic agents in neurosurgery].

Haemostasis is of fundamental significance in neurosurgery, and insufficient control of bleeding is associated with morbidity and mortality. Topical haemostatic agents play an important role, as the characteristics of neuronal tissue limit the use of classical surgical haemostasis techniques. Appropriate choice of agent depends on the location and type of bleeding, but also on knowledge of the products' mechanisms of action, indications, price and accessibility. Biological products are superior to the mechanical in efficacy but require more preparation and are significantly more cost-intensive.

Thrombin generation and factor X assays for the assessment of warfarin anticoagulation in thrombotic antiphospholipid syndrome.

Monitoring warfarin anticoagulation in patients with thrombotic antiphospholipid syndrome (APS) may be complicated by the sensitivity of different thromboplastins to lupus anticoagulant. The aim of this study was to compare the degree of anticoagulation intensity in thrombotic APS and non-APS patients (50 in each group) on long-term warfarin, by measurement of the INR with two widely available thromboplastins with instrument-specific ISI values, and to investigate the potential role of amidolytic FX levels and thrombin generation (TG) testing in the assessment of anticoagulant intensity in thrombotic APS patients. There were no overall differences in INR between reagents or patient groups, but 20% (10/50) of APS patients showed ≥0.5 INR unit difference between reagents, which would have resulted in altered clinical management in some patients. FX levels were useful in assessing anticoagulation intensity for INR 2.0-3.0, but showed poor utility at INR ≥3.5 where the lowest measured FX level was 12IU/dL. In contrast, ETP and peak thrombin showed significant inverse correlations with the INR, suggesting that TG testing may be helpful in the determination of true anticoagulant intensity in APS patients, including those with ≥3.5 INR. TG testing also highlighted a subgroup of APS patients with increased peak thrombin relative to the intensity of anticoagulation as assessed by INR and FX, suggesting that TG testing may be useful in identifying an ongoing prothrombotic state in patients with apparently adequate anticoagulation intensity as assessed by INR.

Use of topical hemostatic agents in gynecologic surgery.

Sutures, hemoclips, and electrocautery are the primary mechanisms used to achieve hemostasis during gynecologic surgery, but in situations in which these are inadequate or not feasible, an array of hemostatic agents are available to help achieve hemostasis. These agents include physical agents such as cellulose, collagen, or gelatin products as well as biologic agents such as thrombin and fibrin products. Limited data are available on many of these agents, although their use is increasing, sometimes at high costs. In gynecologic surgery, hemostatic agents are likely most effective when used in areas of oozing or slow bleeding and as an adjunct to conventional surgical methods of hemostasis.

A cost effective endovascular approach for management of post-catheterization profunda femoris artery pseudoaneurysm using thrombin.

Post-catheterization PSA is one of the most commonly encountered vascular complications of cardiac and peripheral angiographic procedures. We report the case of patient who developed deep-seated profunda femoris artery pseudoaneurysm (PSA) following cardiac catheterization. Despite, repeated ultrasound guided compressions the PSA failed to close and instead produced local site pressure ulcers. The secondary infection followed which precluded use of percutaneous thrombin injection. The PSA was finally closed via a total endovascular technique combining intravascular thrombin injection and coil embolization, thus obviating the need for expensive measures like cover stents or invasive surgical repairs.

Concomitant infusion of low doses of rFVIIa and FEIBA in haemophilia patients with inhibitors.

Patients with severe haemophilia A and an inhibitor may become refractory to FEIBA and/or recombinant factor VIIa (rFVIIa). Sequential therapy with both products has been reported in such patients. In this pilot study, we examined the safety and efficacy of combined rFVIIa and FEIBA therapy in patients with haemophilia A and inhibitors during bleeding episodes. We also tried to evaluate whether thrombin generation (TG), by various mixtures of these agents, can serve as a guide for tailoring therapy. TG was measured in plasma taken from eight haemophilia A patients. Increasing concentrations of rFVIIa, FEIBA or both were added ex vivo to the plasmas, and TG was induced by recalcification. Since low concentrations of rFVIIa and FEIBA had either an additive or a synergistic effect in all patients, the lowest combination, yielding TG comparable or lower than TG achieved with either FEIBA 100 U kg(-1) or rFVIIa 160 microg kg(-1) alone, was selected for the treatment of bleeding episodes. Five patients with a high titre of an inhibitor (8-1300 BU), including one previously refractory to infusions of rFVIIa at doses up to 400 microg kg(-1) X4 daily, were treated with combinations of 30-70 microg kg(-1) rFVIIa and 20-30 U kg(-1) FEIBA during a total number of 400 bleeding episodes with excellent haemostatic effect. No adverse events and no DIC were observed following these infusions. Concomitant infusion of low-dose rFVIIa and low-dose FEIBA, seems to be safe, efficacious and economical in patients refractory to rFVIIa and probably other haemophilia A patients with an inhibitor.

Assessment of topical hemostats in a renal hemorrhage model in heparinized rats.

Various topical hemostatic agents or devices have been employed to address the challenges associated with hemorrhage from parenchymal organs during surgery or trauma. Their relative efficacy, however, has not been assessed in a single animal model. The objective of this study was to develop a small animal renal hemorrhage model for comparing hemostatic efficacy of various topical agents, and then to compare fibrin sealant (FS) to an existing standard of care for topical hemostasis. A left heminephrectomy was performed in anesthetized adult male Sprague-Dawley rats. Animals were anticoagulated with 2000 IU/kg heparin IV and various topical hemostatic agents were applied to the injury. Treatment groups included FS applied as a spray; FS applied through a cannula; gelatin sponge (GS) soaked in 1000 IU/mL thrombin solution; GS soaked in 300 IU/mL thrombin; dry GS; and fibrinogen without thrombin applied as a spray. The main endpoints of the study were incidence of hemostasis, blood loss, acute survival trends, and maintenance of mean arterial pressure (MAP). Three treatment groups, the two FS groups and the GS soaked in 1000 IU/mL thrombin, afforded significant hemostasis compared to the controls (P < 0.01). Both FS groups had significantly less blood loss, longer survival times, and maintained higher MAPs than the GS-treated groups. Quantitative dose effects and functional deficiencies in topical hemostatic products could be assessed using this animal model. The study demonstrated that liquid FS was significantly more efficacious than a GS soaked in thrombin for abating hemorrhage from a renal excision in a heparinized rat.