Explore the vast range of titles available.

This Phase I/II randomized, controlled, multicenter study aimed to evaluate the safety and efficacy of sFilm-FS compared to Tachosil® in patients undergoing elective liver surgery requiring hemostasis at the liver surface. sFilm-FS is a new fibrin sealant patch, coating on a biodegradable tri-block polymeric film. The trial included 33 patients randomized 1:1 to receive sFilm-FS or Tachosil®. While most patients underwent liver resection, a subset underwent other hepatic surgical interventions. Safety was the primary outcome, including treatment-emergent adverse events, coagulopathies, and intraoperative blood loss. Efficacy was assessed as secondary endpoints by the time to hemostasis and hemostasis at 2, 3, 5, 7, and 10 ​min from product application. Hemostasis was defined as the absence of bleeding at the target bleeding site within 10 ​min. Both treatments were well tolerated, with no significant differences in adverse events. All patients achieved hemostasis within 10 ​min. The median time to hemostasis was 2 ​min for sFilm-FS and 3 ​min for Tachosil®. sFilm-FS is a promising, well tolerated, fibrin sealant patch, offering the potential for a superior Fibrin Sealant patch that could improve surgical outcomes. Further studies are recommended to validate these findings in larger populations. •SFilm-FS achieved faster median hemostasis (2 ​min) vs. Tachosil (3 ​min) in liver resection.•No anti-fibrinogen antibody response detected in sFilm-FS patients during 6-month follow-up.•SFilm-FS is semi-transparent, enabling clear visibility of the target bleeding site.•SFilm-FS demonstrated suitability for minimal invasive surgery due to its thin, flexible structure.•SFilm-FS contains significantly lower fibrinogen levels, reducing production costs and immunogenicity risk.

ObjectivesThe goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery.DesignProspective, two-arm, randomised, double-blind pilot trial.SettingSingle-centre study conducted at a tertiary care hospital specialising in scoliosis surgery.Participants32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age <18 years, provision of a signed informed consent form by both parents and consent to contraception use for the duration of this clinical trial among sexually active (≥15 years of age) participants. The exclusion criteria were diagnosed congenital or acquired coagulopathy, use of anticoagulants other than perioperative prophylactic administration of low molecular weight heparin to prevent venous thromboembolism, known hypersensitivity to the active substance or any excipients in the investigated medicinal product, history of deep vein thrombosis or pulmonary embolism, pregnancy and lactation.InterventionsParticipants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care.Primary and secondary outcome measuresSafety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes.ResultsIn the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p>0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups.ConclusionsThis study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial.Trial registration numberCliniacalTrials.gov NCT05391412.

Background Fibrinogen is the first coagulation protein to reach critical levels during traumatic haemorrhage. This laboratory study compares paired plasma samples pre- and post-fibrinogen replacement from the Fibrinogen Early In Severe Trauma studY (FEISTY; NCT02745041). FEISTY is the first randomised controlled trial to compare the time to administration of cryoprecipitate (cryo) and fibrinogen concentrate (Fg-C; Riastap) in trauma patients. This study will determine differences in clot strength and fibrinolytic stability within individuals and between treatment arms. Methods Clot lysis, plasmin generation, atomic force microscopy and confocal microscopy were utilised to investigate clot strength and structure in FEISTY patient plasma. Results Fibrinogen concentration was significantly increased post-transfusion in both groups. The rate of plasmin generation was reduced 1.5-fold post-transfusion of cryo but remained unchanged with Fg-C transfusion. Plasminogen activator inhibitor 1 activity and antigen levels and Factor XIII antigen were increased post-treatment with cryo, but not Fg-C. Confocal microscopy analysis of fibrin clots revealed that cryo transfusion restored fibrin structure similar to those observed in control clots. In contrast, clots remained porous with stunted fibres after infusion with Fg-C. Cryo but not Fg-C treatment increased individual fibre toughness and stiffness. Conclusions In summary, our data indicate that cryo transfusion restores key fibrinolytic regulators and limits plasmin generation to form stronger clots in an ex vivo laboratory study. This is the first study to investigate differences in clot stability and structure between cryo and Fg-C and demonstrates that the additional factors in cryo allow formation of a stronger and more stable clot.

The aim of this study is to evaluate the effectiveness of TachoSil sponge on distal pancreatectomy remnant stump in reducing the rate and severity of postoperative pancreatic fistula (POPF). All consecutive patients requiring distal pancreatectomy were randomized in 45 centers. The principal end point was onset of “clinically relevant” POPF. Univariate and multivariate analyses were searched for predictive factors. Of the 270 patients randomized (134 with TachoSil; 136 without), 150 (55.6%) patients sustained a POPF [74 clinically relevant and 76 clinically silent (27.4% and 28.1%), respectively]: no statistically significant difference was found between patients sustaining clinically relevant POPF [41 (30.6%) with vs 33 (24.3%) without TachoSil (P = .276)], or overall POPF [73 (54.5%) with vs 77 (56.6%) without TachoSil, (P = .807)], but there were more clinically relevant POPF after hand-sewn (32.3%) versus mechanical closure (19.8%) (P = .025) and, in case of splenic preservation, after splenic vessel ligation (15/32, 46.9%) versus vascular preservation (17/72, 23.6%) (P = .024). Hand-sewn pancreatic remnant closure (P = .023) and splenic vessel ligation in splenic preservation (P = .035) were independent predictive factors for the onset of clinically relevant POPF. TachoSil sponge reinforcement of the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF. •Several procedures have been proposed to reduce the rate and/or severity of POPF.•This multicenter controlled randomized trial evaluated the usefulness of TachoSil sponge on remnant stump in reducing the rate and severity of POPF.•TachoSil sponge on the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF.•Hand-sewn pancreatic remnant closure and splenic vessel ligation in splenic preservation were independent predictive factors for the onset of clinically patent POPF.•Negative studies must be published to avoid publication and reporting bias before drawing methodologically sound conclusions as to the usefulness or futility of therapeutic decisions.

The debate on replacing coagulation factors and its effect on the final outcome of the patients with acute traumatic coagulopathy (ATC) in need of transfusion is still ongoing. Therefore, the present study is designed with the aim of comparing the outcome of patients with acute traumatic coagulopathies receiving fibrinogen and fresh frozen plasma (FFP). In this quasi-experimental randomized controlled study, patients with severe blunt trauma (ISS>16) and in need of packed cells transfusion were divided into 3 groups of receiving fibrinogen, receiving FFP, and control, and their final outcome was compared. 90 patients with the mean age of 33.16±16.32years were randomly allocated to one of the 3 study groups (82.2% male). The 3 groups were similar regarding baseline characteristics. Patients receiving fibrinogen needed significantly less packed cells (p=0.044) and intravenous fluid in the initial 24h of hospitalization (p=0.022). In addition, mortality rate (p=0.029), need for admission to intensive care unit (p=0.020) and duration of hospitalization (p=0.045) were also lower in the group receiving fibrinogen. The number of sepsis cases in patients receiving fibrinogen and control group was lower than those who received FFP (p=0.001). The number of multiple organ failure cases in patients receiving fibrinogen was about one fourth of the other 2 groups (p=0.106), and a fewer number of them needed mechanical ventilation (p=0.191). No case of venous thrombosis was detected in any of the 3 groups. Multiple trauma patients in need of transfusion who received fibrinogen along with packed cells had significantly better outcomes regarding mortality, sepsis, need for admission to the intensive care unit, need for receiving packed cells, need for receiving intravenous fluids in the initial 24h, and duration of hospitalization.

Traumatic brain injury (TBI) is strongly associated with coagulopathy that occurs in 25–35% of patients. This complication is linked to higher mortality and morbidity. Recent lines of evidance have supported administration of fibrinogen concentrate (FC) in patients with severe TBI, while its efficacy remains controversial. In this study we aim to evaluate the effectiveness of serum fibrinogen level correction from 1.5 and 2.0 g/l to more than 2.0 g/l in patients with severe TBI undergoing traumatic cranial surgery. This randomized, single-blind, placebo-controlled clinical trial included trauma patients who had abbreviated injury scale (AIS) more than 3 in head and below 3 in other organs. FC was administered intravenously to patients with severe TBI undergoing TBI to correct the fibrinogen level above 2 g/l. Patients were randomly assigned to FC and control groups. The amount of intra-operative blood loss, packed cell (PC) transfusion, formation of new intracranial hemorrhage, and hemovac drainage were compared between the two study groups. Forty-seven of 65 participants received the study intervention within 40–112 min of admission. Intra-operative PC transfusion was higher in FC group (80%) compared to control group (55.5%) while the differance was not statistically significant (p > 0.05). Intra-operative blood loss was significantly higher in control group than FC group (P = 0.036). Chance of re-operation and new intracranial hematoma were not significantly different between two study groups. Early delivery of FC, decreases intraoperative bleeding. Although based on our findings it has no other effect on other parameters, further multicenter studies are recommended to investigate the role of early FC administration in management of post traumatic coagulopathy. •Early delivery of Fibrinogen concentrate, decreases intraoperative bleeding.•Fibrinogen has no other effect on other blood parameters.•Early administration of fibrinogen does not affect the prognosis of the patients with TBI.

BackgroundSeveral studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer.MethodsIn a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage.ResultsBetween March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512–895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) −110 ml, 95% CI −316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625–35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771–34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3–1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1–4) vs. 5.5 days (95% CI 2–11); p = 0.2].ConclusionsTachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.

IntroductionFibrinogen is one of the essential coagulation factors. Preoperative lower plasma fibrinogen level has been associated with higher blood loss. Scoliosis surgery presents a challenge for the anaesthetic team, one of the reasons being blood loss and transfusion management. Recently, the prophylactic fibrinogen administration has been a debated topic in various indications. It has been described for example, in urological or cardiovascular surgery, as well as in paediatrics. This pilot study is focused on verifying the feasibility of potential large randomised trial and verifying the safety of prophylactic fibrinogen administration in paediatric scoliosis surgery.Methods and analysisA total of 32 paediatric patients indicated for scoliosis surgery will be recruited. Participants will be randomised into study groups in a 1:1 allocation ratio. Patients in the intervention group will receive prophylactic single dose of fibrinogen, in addition to standard of care. Patients in the control group will receive standard of care without study medication prior to skin incision. The primary aim is to assess the safety of prophylactic fibrinogen administration during scoliosis surgery in children, the incidence of any adverse events (AEs) and reactions will be monitored during participation in the study. The secondary objective is to investigate the additional safety information, feasibility and efficacy of a prophylactic fibrinogen administration. The incidence of AEs and reactions according to selected adverse events of special interest will be monitored. All collected data will be subjected to statistical analysis according to a separate statistical analysis plan.Ethics and disseminationThis trial follows the applicable legislation and requirements for good clinical practice according to the International Conference on Harmonisation E6(R2). All essential trial documents were approved by the relevant ethics committee and national regulatory authority (State Institute for Drug Control) and their potential amendments will be submitted for approval.Trial registration numberNCT05391412.

IntroductionTrauma causes 40% of child deaths in high-income countries, with haemorrhage being a leading contributor to death in this population. There is a growing recognition that fibrinogen and platelets play a major role in trauma-induced coagulopathy (TIC) but the exact physiological mechanisms are poorly understood.Methods and analysisThis is a prospective multicentre, open-label, randomised, two-arm parallel feasibility study conducted in the emergency departments, intensive care units and operating theatres of participating hospitals. Severely injured children, aged between 3 months and 18 years, presenting with traumatic haemorrhage requiring transfusion of blood products will be screened for inclusion.Sixty-eight patients will be recruited and will be allocated to fibrinogen replacement using fibrinogen concentrate (FC) or cryoprecipitate in a 1:1 ratio. Fibrinogen replacement will be administered to patients with a FIBTEM A5 of ≤10. All other aspects of the currently used rotational thromboelastometry-guided treatment algorithm and damage-control approach to trauma remain the same in both groups.The primary outcome is time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia. Clinical secondary outcomes and feasibility outcomes will also be analysed.Ethics and disseminationThis study has received ethical clearance from the Children’s Health Queensland Human Research Ethics Committee (HREC/17/QRCH/78). Equipment and consumables for sample testing have been provided to the study by Haemoview Diagnostics, Werfen Australia and Haemonetics Australia. FC has been provided by CSL Behring, Australia. The funding bodies and industry partners have had no input into the design of the study, and will not be involved in the preparation or submission of the manuscript for publication.The use of viscoelastic haemostatic assays and early fibrinogen replacement has the potential to improve outcomes in paediatric trauma through earlier recognition of TIC. This in turn may reduce transfusion volumes and downstream complications and reduce the reliance on donor blood products such as cryoprecipitate.The use of FC has implications for regional and remote centres who would not routinely have access to cryoprecipitate but could store FC easily. Access to early fibrinogen replacement in these centres could make a significant impact and assist in closing the gap in trauma care available to residents of these communities.Outcomes of this study will be submitted for publication in peer-reviewed journals and submitted for presentation at national and international scientific fora.Trial registration number NCT03508141.

Purpose To evaluate the effect of a collagen-fibrin sealant patch (TachoSil®) in preventing postoperative complications after inguinofemoral lymphadenectomy for vulvar cancer. Methods Double-blind randomized-controlled trial on consecutive patients undergoing bilateral inguinofemoral lymphadenectomy for vulvar cancer. Intraoperatively, inguinofemoral areas were randomized: one was treated with TachoSil®, while the contralateral had standard closure without collagen-fibrin sealant patch. Surgical outcomes, amount of drainage volume, duration of drain placement, and any postoperative complication (vulvar wound dehiscence, inguinal wound dehiscence, cellulitis, lymphangitis, lymphoceles, and hematoma) were recorded. Leg measurements were taken preoperatively and during postoperative follow-up until 6 months to evaluate lymphedema. Results A total of 19 patients were enrolled and 38 inguinofemoral dissections were performed. There was no significant difference between the investigational and control arm in the amount of drainage volume ( p  = 0.976), and duration of drain placement ( p  = 0.793). The postoperative complications, excluding lymphedema, were 10/19 (53%) in investigational arm and 9/19 (47%) in control arm ( p  = 0.74). At the end of follow-up, the prevalence of grade 1 lymphedema was 44.4% and 50% in investigational and control arm, respectively ( p  = 0.744); grade 2 and 3 lymphedema had a prevalence of 33.3% in both arms ( p  = 1). Conclusion Application of TachoSil® does not seem to improve postoperative lymphorrhagia nor to reduce the incidence of postoperative complications in patients undergoing inguinofemoral lymphadenectomy for vulvar cancer. Considering this point, it would be useful to identify additional strategies in inguinofemoral dissection for the prevention of these complications.