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Borayflo Haemostatic matrix is a new absorbable hemostatic gelatin matrix which can be used for intraoperative assisted hemostasis. In a prospective, multicenter, non-inferiority, randomized controlled trial, a total of 354 subjects were recruited from the departments of hepatobiliary surgery, obstetrics and gynaecology and orthopaedics of 4 hospitals and randomly allocated to test group (Borayflo Haemostatic matrix) or control group (Surgiflo Haemostatic matrix) in a 1:1 ratio. In the modified intention-to-treat population, 163 (93.14%) of 175 subjects in the test group versus 167 (94.89%) of 176 subjects in the control group successfully achieved hemostasis within 5 min ( P  > 0.05). Non-inferiority for effective rates of hemostasis at 5 min to Surgiflo Haemostatic matrix was shown in the study (treatment difference: -1.74% [95%CI, -6.70–3.22%] for modified intention-to-treat population). In terms of efficacy and safety, the new hemostatic gelatin matrix (Borayflo Haemostatic matrix) is equivalent to Surgiflo Haemostatic matrix. There was no significant difference in the incidence of AEs or SAEs between the test and control groups( P  > 0.05). In addition, Borayflo Haemostatic matrix is a domestically produced haemostatic gelatin product, an advantage that will reduce the cost of surgical haemostasis for Chinese patients.

Objective To examine whether prospective bleeding risk estimates for patients undergoing percutaneous coronary intervention could improve the use of bleeding avoidance strategies and reduce bleeding.Design Prospective cohort study comparing the use of bleeding avoidance strategies and bleeding rates before and after implementation of prospective risk stratification for peri-procedural bleeding.Setting Nine hospitals in the United States.Participants All patients undergoing percutaneous coronary intervention for indications other than primary reperfusion for ST elevation myocardial infarction.Main outcome measures Use of bleeding avoidance strategies, including bivalirudin, radial approach, and vascular closure devices, and peri-procedural bleeding rates, stratified by bleeding risk. Observed changes were adjusted for changes observed in a pool of 1135 hospitals without access to pre-procedural risk stratification. Hospital level and physician level variability in use of bleeding avoidance strategies was examined. Results In a comparison of 7408 pre-intervention procedures with 3529 post-intervention procedures, use of bleeding avoidance strategies within intervention sites increased with pre-procedural risk stratification (odds ratio 1.81, 95% confidence interval 1.44 to 2.27), particularly among higher risk patients (2.03, 1.58 to 2.61; 1.41, 1.09 to 1.83 in low risk patients, after adjustment for control sites; P for interaction=0.05). Bleeding rates within intervention sites were significantly lower after implementation of risk stratification (1.0% v 1.7%; odds ratio 0.56, 0.40 to 0.78; 0.62, 0.44 to 0.87, after adjustment); the reduction in bleeding was greatest in high risk patients. Marked variability in use of bleeding avoidance strategies was observed across sites and physicians, both before and after implementation.Conclusions Prospective provision of individualized bleeding risk estimates was associated with increased use of bleeding avoidance strategies and lower bleeding rates. Marked variability between providers highlights an important opportunity to improve the consistency, safety, and quality of care.Study registration Clinicaltrials.gov NCT01383382.

Hemostatic materials are of great importance in medicine. However, their successful implementation is still challenging as it depends on two, often counteracting, attributes; achieving blood coagulation rapidly, before significant blood loss, and enabling subsequent facile wound-dressing removal, without clot tears and secondary bleeding. Here we illustrate an approach for achieving hemostasis, rationally targeting both attributes, via a superhydrophobic surface with immobilized carbon nanofibers (CNFs). We find that CNFs promote quick fibrin growth and cause rapid clotting, and due to their superhydrophobic nature they severely limit blood wetting to prevent blood loss and drastically reduce bacteria attachment. Furthermore, minimal contact between the clot and the superhydrophobic CNF surface yields an unforced clot detachment after clot shrinkage. All these important attributes are verified in vitro and in vivo with rat experiments. Our work thereby demonstrates that this strategy for designing hemostatic patch materials has great potential. Nanotechnology can bring significant advancements to hemostatic patches. Here, the authors design a superhydrophobic hemostatic surface with immobilized carbon nanofibers that can stop bleeding instantaneously upon application, seal the wound subsequently by promoting quick fibrin formation, and facilitate unforced and facile patch removal without tearing the wound.

Background Excessive intraoperative bleeding remains a challenge in limb surgeries. The exsanguination tourniquet ring has emerged as a potential solution for effective exsanguination and hemostasis. This study aims to evaluate its efficacy and safety compared to the conventional exsanguination and hemostasis approach (pneumatic tourniquet combined with Esmarch bandage). Methods This randomized controlled trial evaluates the exsanguination tourniquet ring’s effectiveness and safety versus the conventional approach in 220 participants undergoing various limb surgeries. Allocation included experimental and control groups, assesses through efficacy (including intraoperative and total blood loss, hemoglobin levels, and exsanguination and hemostasis effectiveness) and safety (adverse event occurrence) indicators. Results The experimental group ( n  = 110) utilizes the exsanguination tourniquet ring, while the control group ( n  = 110) employs the conventional approach. As for intraoperative blood loss, the experimental group is non-inferior to the control group ( p -value < 0.001). While no significant difference is found in total blood loss (for the full analysis set, p -value = 0.442; for the per protocol set, p -value = 0.976) and differences in postoperative and preoperative hemoglobin levels (for the full analysis set, p -value = 0.502; for the per protocol set, p -value = 0.928). Regarding exsanguination and hemostasis effectiveness, the full analysis set reveals significantly superior ratings in the experimental group compared to the control group ( p -value = 0.002 < 0.05), while the per protocol set analysis indicates no significant difference between the groups ( p -value = 0.504). As for safety indicators, adverse events related to the device are minimal in two groups, with only one severe event unrelated to the device. Conclusions The exsanguination tourniquet ring is an effective and safe device for intraoperative blood loss control in various limb surgeries. Trial registration Comparison of Exsanguination and Hemostasis Devices for Limb Surgery A Prospective Multicenter Randomized Controlled Study, ChiCTR2300077998, 11/27/2023.

Platelet and fibrin clots occlude blood vessels in hemostasis and thrombosis. Here we report a noncanonical mechanism for vascular occlusion based on neutrophil extracellular traps (NETs), DNA fibers released by neutrophils during inflammation. We investigated which host factors control NETs in vivo and found that two deoxyribonucleases (DNases), DNase1 and DNase1-like 3, degraded NETs in circulation during sterile neutrophilia and septicemia. In the absence of both DNases, intravascular NETs formed clots that obstructed blood vessels and caused organ damage. Vascular occlusions in patients with severe bacterial infections were associated with a defect to degrade NETs ex vivo and the formation of intravascular NET clots. DNase1 and DNase1-like 3 are independently expressed and thus provide dual host protection against deleterious effects of intravascular NETs.

BackgroundHybrid endoscopic submucosal dissection (ESD) incorporates snare-assisted resection to reduce technical difficulty and perforation risk in anatomically complex colon lesions. The All In OneTM (AIO) snare probe, which integrates an ESD knife, needle injector, snare, and argon gas spray - facilitates complete lesion removal using a single instrument during hybrid ESD. This study aims to evaluate the efficacy and safety of the AIOTM snare probe for large colorectal polyp during hybrid ESD.MethodsThis prospective single-arm multicenter trial enrolled patients from five clinical centers between November 2021 and November 2022, who presented with sessile, sub-pedunculated, or broad-based polyp measured 1–3 cm in diameter. All patients underwent hybrid ESD assisted by the AIOTM device. The primary outcome was the en bloc resection rate. The secondary outcomes were complete resection rate, hemostasis success rate, device-related adverse events, intraoperative/postoperative bleeding and perforation occurrences.ResultsA total of 161 patients ultimately enrolled in the study, with 173 target polyps removed by AIOTM (IDDF2025-ABS-0051 figure 1). The average polyp diameter was 1.42 ± 0.47 cm (range 1–3 cm). The en bloc resection rate was 94.8% (164/173) (95% CI: 90.4% - 97.6%). The complete resection rate was 95.4% (165/173) (95% CI: 91.1% - 98.0%), and the hemostasis success rate was 94.2% (163/173) (95% CI: 89.6% - 97.2%). Device-related adverse events occurred in 1.2% (2/161) of patients, both cases involving delayed bleeding. No intraoperative perforation or delayed perforation was reported.Abstract IDDF2025-ABS-0051 Figure 1ConclusionsIn this study, we demonstrated that the AIOTM device achieved favorable efficacy and safety during hybrid ESD procedures. Further large-scale studies are needed.

ObjectiveThis study evaluated the application of the bipolar electrocoagulation catheter via a peripheral-to-central (3 + 1) technique, relative to directly pressing only at the center of the bleeding site (direct-stroke), to effect endoscopic hemostasis of acute non-varicose gastrointestinal bleeding (ANVUGIB).MethodsPatients (n = 148) with endoscopically diagnosed ANVUGIB were randomly apportioned to receive treatment by 3 + 1 (n = 78) or direct-stroke (n = 70) application of the bipolar electrocoagulation catheter. The 3 + 1 strategy required pressing at3 narrowly restricted sites equidistant peripheral and center to the site of bleeding. The rates of initial success, hemostasis time, and number of compressions were compared according to intention-to-treat (ITT) or per protocol (PP).ResultsThe ITT (PP) rate of initial hemostatic success in patients receiving the 3 + 1 catheter was 91.02% (95.9%); and for the direct-stroke group was 71.42% (76.9%). For Forrest IIa lesions specifically, these rates were respectively 91.70% (97.1%) and 63.9% (67.6%). The ITT (PP) hemostasis times of the 3 + 1 and direct-stroke groups were 10.96 ± 3.28 (10.65 ± 2.90) and 14.27 ± 6.58 (14.12 ± 6.67) min; and the number of compressions numbered 5.73 ± 1.98 (5.42 ± 1.46) and 6.47 ± 2.82 (6.16 ± 2.47).ConclusionDuring thermocoagulation treatment of ANVUGIB via bipolar electrocoagulation catheter, the 3 + 1 strategy showed a significantly higher rate of successful initial hemostasis relative to the direct-stroke technique, and shorter hemostasis time, with no increase in total procedural steps.

The development of materials that effectively stop bleeding and prevent wound adhesion is essential in both military and medical fields. However, traditional hemostasis methods, such as cautery, tourniquets, and gauze, have limitations. In recent years, new nanomaterials have gained popularity in medical and health fields due to their unique microstructural advantages. Compared to traditional materials, nanomaterials offer better adhesion, versatility, and improved bioavailability of traditional medicines. Nanomaterials also possess advantages such as a high degree and stability, self-degradation, fewer side effects, and improved wound healing, which make them ideal for the development of new hemostatic materials. Our review provides an overview of the currently used hemostatic strategies and materials, followed by a review of the cutting-edge nanomaterials for hemostasis, including nanoparticles and nanocomposite hydrogels. The paper also briefly describes the challenges faced by the application of nanomaterials for hemostasis and the prospects for their future development.

Rapid reversal of vitamin K antagonist (VKA)-induced anticoagulation is often necessary for patients needing urgent surgical or invasive procedures. The optimum means of VKA reversal has not been established in comparative clinical trials. We compared the efficacy and safety of four-factor prothrombin complex concentrate (4F-PCC) with that of plasma in VKA-treated patients needing urgent surgical or invasive procedures. In a multicentre, open-label, phase 3b randomised trial we enrolled patients aged 18 years or older needing rapid VKA reversal before an urgent surgical or invasive procedure. We randomly assigned patients in a 1:1 ratio to receive vitamin K concomitant with a single dose of either 4F-PCC (Beriplex/Kcentra/Confidex; CSL Behring, Marburg, Germany) or plasma, with dosing based on international normalised ratio (INR) and weight. The primary endpoint was effective haemostasis, and the co-primary endpoint was rapid INR reduction (≤1·3 at 0·5 h after infusion end). The analyses were intended to evaluate, in a hierarchical fashion, first non-inferiority (lower limit 95% CI greater than −10% for group difference) for both endpoints, then superiority (lower limit 95% CI >0%) if non-inferiority was achieved. Adverse events and serious adverse events were reported to days 10 and 45, respectively. This trial is registered at ClinicalTrials.gov, number NCT00803101. 181 patients were randomised (4F-PCC n=90; plasma n=91). The intention-to-treat efficacy population comprised 168 patients (4F-PCC, n=87; plasma, n=81). Effective haemostasis was achieved in 78 (90%) patients in the 4F-PCC group compared with 61 (75%) patients in the plasma group, demonstrating both non-inferiority and superiority of 4F-PCC over plasma (difference 14·3%, 95% CI 2·8–25·8). Rapid INR reduction was achieved in 48 (55%) patients in the 4F-PCC group compared with eight (10%) patients in the plasma group, demonstrating both non-inferiority and superiority of 4F-PCC over plasma (difference 45·3%, 95% CI 31·9–56·4). The safety profile of 4F-PCC was generally similar to that of plasma; 49 (56%) patients receiving 4F-PCC had adverse events compared with 53 (60%) patients receiving plasma. Adverse events of interest were thromboembolic adverse events (six [7%] patients receiving 4F-PCC vs seven [8%] patients receiving plasma), fluid overload or similar cardiac events (three [3%] patients vs 11 [13%] patients), and late bleeding events (three [3%] patients vs four [5%] patients). 4F-PCC is non-inferior and superior to plasma for rapid INR reversal and effective haemostasis in patients needing VKA reversal for urgent surgical or invasive procedures. CSL Behring.

This study investigated the role of titanium clip marking during endoscopy in managing patients with upper gastrointestinal bleeding (UGIB) for whom endoscopic hemostasis has proven ineffective. A total of 63 UGIB patients admitted to the Affiliated Hospital of Zunyi Medical University between January 2018 and November 2020 were selected as the study cohort. Patients were randomly assigned to one of two groups: the control group (n=23) and the combined group (n=40). The control group underwent transcatheter arterial embolization (TAE), while the combined group received endoscopic metallic titanium clip-assisted TAE. This study compared the rates of successful embolization, clinical success, recurrence, operation time, radiation exposure time, radiation dosage, levels of hs-CRP, Cor, NE, TNF-α, IL-6, and ADH before and after treatment, as well as postoperative complications between the two groups. The combined group of patients exhibited significantly higher rates of successful embolization and clinical success compared to the control group (P < .05). Additionally, the recurrence rate and levels of hs-CRP, Cor, NE, TNF-α, IL-6, and ADH were significantly lower in the combined group compared to the control group (P < .05). Furthermore, patients in the combined group had shorter operation times, reduced radiation exposure times, and lower radiation dosages compared to the control group (P < .05). There was no statistically significant difference in the occurrence of postoperative complications between the two groups (P > .05). Using titanium clip marking during endoscopy provides valuable guidance in managing patients with upper gastrointestinal bleeding who have not responded to endoscopic hemostasis. This finding is especially relevant in digital subtraction angiography (DSA) and transcatheter arterial embolization (TAE) treatments. It enhances the clinical efficacy and safety of the procedure.