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1.
Cochrane Database Syst Rev ; 5: CD013421, 2024 May 02.
Article En | MEDLINE | ID: mdl-38695613

BACKGROUND: During vascular interventions, connections that link arteries, veins, or synthetic grafts, which are known as an 'anastomosis', may be necessary. Vascular anastomoses can bleed from the needle holes that result from the creation of the anastomoses. Various surgical options are available for achieving hemostasis, or the stopping of bleeding, including the application of sealants directly onto the bleeding vessels or tissues. Sealants are designed for use in vascular surgery as adjuncts when conventional interventions are ineffective and are applied directly by the surgeon to seal bleeding anastomoses. Despite the availability of several different types of sealants, the evidence for the clinical efficacy of these hemostatic adjuncts has not been definitively established in vascular surgery patients. OBJECTIVES: To evaluate the benefits and harms of sealants as adjuncts for achieving anastomotic site hemostasis in patients undergoing vascular surgery. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the following databases: the Cochrane Vascular Specialised Register via the Cochrane Register of Studies; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid; Embase via Ovid ; and CINAHL via EBSCO. We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for clinical trials. Reference lists of included trials and relevant reviews were also searched. The latest search date was 6 March 2023. SELECTION CRITERIA: We included randomized controlled trials that compared fibrin or synthetic sealant use with alternative interventions (e.g. manual compression, reversal of anticoagulation) for achieving anastomotic-site hemostasis in vascular surgery procedures. We included participants who underwent the creation of an anastomosis during vascular surgery. We excluded non-vascular surgery patients. DATA COLLECTION AND ANALYSIS: We have used standard Cochrane methods. Our primary outcomes were time to hemostasis, failure of hemostatic intervention, and intraoperative blood loss. Our secondary outcomes were operating time, death from bleeding complications up to 30 days, postoperative bleeding up to 30 days, unplanned return to the operating room for bleeding complications management up to 30 days, quality of life, and adverse events. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We found 24 randomized controlled trials that included a total of 2376 participants who met the inclusion criteria. All trials compared sealant use with standard care controls, including oxidized cellulose, gelatin sponge, and manual compression. All trials were at high risk of performance bias, detection bias, and other sources of bias. We downgraded the certainty of evidence for risk of bias concerns, inconsistency, imprecision and possible publication bias. Combining data on time to hemostasis showed that sealant use may reduce the mean time to hemostasis compared to control (mean difference (MD) -230.09 seconds, 95% confidence interval (CI) -329.24 to -130.94; P < 0.00001; 7 studies, 498 participants; low-certainty evidence). Combining data on failure of hemostatic intervention showed that sealant use may reduce the rate of failure compared to control, but the evidence is very uncertain (risk ratio (RR) 0.46, 95% CI 0.35 to 0.61; P < 0.00001; 17 studies, 2120 participants; very low-certainty evidence). We did not detect any clear differences between the sealant and control groups for intraoperative blood loss (MD -32.69 mL, 95% CI -96.21 to 30.83; P = 0.31; 3 studies, 266 participants; low-certainty evidence); operating time (MD -18.72 minutes, 95% CI -40.18 to 2.73; P = 0.09; 4 studies, 436 participants; low-certainty evidence); postoperative bleeding (RR 0.78, 95% CI 0.59 to 1.04; P = 0.09; 9 studies, 1216 participants; low-certainty evidence), or unplanned return to the operating room (RR 0.27, 95% CI 0.04 to 1.69; P = 0.16; 8 studies, 721 participants; low-certainty evidence). No studies reported death from bleeding or quality of life outcomes. AUTHORS' CONCLUSIONS: Based on meta-analysis of 24 trials with 2376 participants, our review demonstrated that sealant use for achieving anastomotic hemostasis in vascular surgery patients may result in reduced time to hemostasis, and may reduce rates of hemostatic intervention failure, although the evidence is very uncertain, when compared to standard controls. Our analysis showed there may be no differences in intraoperative blood loss, operating time, postoperative bleeding up to 30 days, and unplanned return to the operating room for bleeding complications up to 30 days. Deaths and quality of life could not be analyzed. Limitations include the risk of bias in all studies. Our review has demonstrated that using sealants may reduce the time required to achieve hemostasis and the rate of hemostatic failure. However, a significant risk of bias was identified in the included studies, and future trials are needed to provide unbiased data and address other considerations such as cost-effectiveness and adverse events with sealant use.


Anastomosis, Surgical , Hemostasis, Surgical , Randomized Controlled Trials as Topic , Vascular Surgical Procedures , Humans , Hemostasis, Surgical/methods , Hemostatics/therapeutic use , Fibrin Tissue Adhesive/therapeutic use , Blood Loss, Surgical/prevention & control , Tissue Adhesives/therapeutic use
2.
World J Surg ; 48(5): 1159-1166, 2024 May.
Article En | MEDLINE | ID: mdl-38578243

BACKGROUND: Axillary lymph node dissection (ALND) in breast cancer management, necessitates a nuanced understanding of complications that may impede treatment progression. This study scrutinize the impact of Haemoblock hemostatic solution, evaluation it's potential in reducing seroma complication by controlling lymph flow and obliterating axillary dead space. METHOD: A prospective, randomized, double-blinded controlled trial was conducted with 58 patients undergoing breast conserving surgery (BCS) and ALND, stratified into two groups: Group A (ALND + Haemoblock, n = 29) and Group B (ALND + placebo, n = 29). Postoperative drainage charts were monitored, with the primary endpoint being the time to drain removal, Additionally, patients were observed for surgical site infection (SSI). RESULTS: Group A exhibited a marginally higher mean total drain output (398 +/- 205 vs. 326 +/- 198) compared to Group B, this difference did not attain statistical significance (p = 0.176). Equally, the mean time to drain removal demonstrated no discernible distinction between the two groups (6 +/- 3.0 vs. 6 +/- 3.0, Group A vs. Group B, p = 0.526). During follow up, nine patients in Group A required seroma aspiration (mean aspiration 31 +/- 73) as compared to Group B, 6 patients required aspiration (mean aspiration 12 +/- 36), p = 0.222). No notable disparity in SSI rates between the groups was identified. CONCLUSION: In conclusion, the administration of Haemoblock did not manifest a discernible effect in mitigating seroma production, hastening drain removal, or influencing SSI rates following ALND. The study underscores the intricate and multifactorial nature of seroma formation, suggesting avenues for future research to explore combined interventions and protracted follow-up periods for a more comprehensive understanding.


Axilla , Breast Neoplasms , Hemostatics , Lymph Node Excision , Mastectomy, Segmental , Seroma , Humans , Seroma/prevention & control , Seroma/etiology , Female , Lymph Node Excision/adverse effects , Lymph Node Excision/methods , Middle Aged , Breast Neoplasms/surgery , Prospective Studies , Double-Blind Method , Mastectomy, Segmental/adverse effects , Mastectomy, Segmental/methods , Hemostatics/therapeutic use , Aged , Drainage , Adult , Treatment Outcome , Surgical Wound Infection/prevention & control , Surgical Wound Infection/etiology , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Postoperative Complications/epidemiology
3.
Clin Oral Investig ; 28(5): 244, 2024 Apr 07.
Article En | MEDLINE | ID: mdl-38583113

OBJECTIVES: To compare oral adhesive bandages with the classic compression method and evaluate the clinical efficacy of this wound dressing material in improving postoperative comfort, wound healing, and hemostasis in tooth extraction. MATERIALS AND METHODS: The study was designed as a randomized controlled clinical trial. A total of 120 patients were recruited and randomly assigned to the study group and the control group. In the study group, oral adhesive bandages were used as wound dressing. In the control group, patients bit on cotton balls and gauze, as usual. Hemorrhage, comfort, and healing levels were evaluated at postoperative 1 h, 24 h, and 7 days. The adhesion time of the oral adhesive bandages was also recorded. RESULTS: The average adhesion time of the oral adhesive bandages was 26.6 h. At postoperative 1 and 24 h, the hemostatic levels of the oral adhesive bandage group were significantly higher than those of the control group. The oral adhesive bandage group also reported significantly higher comfort scores than the control group. Both groups had similar healing levels and side effects. But the mean score for wound healing was slightly higher in the oral adhesive bandage group. CONCLUSIONS: Oral adhesive bandages were more effective than cotton balls and gauze in providing hemostatic and comfort effects on extraction wounds. CLINICAL RELEVANCE: Oral adhesive bandages possess clinical value in the management of extraction wounds.


Hemostatics , Humans , Hemostatics/therapeutic use , Bandages , Tooth Extraction , Dental Care , Hemostasis
4.
Eur J Anaesthesiol ; 41(5): 327-350, 2024 May 01.
Article En | MEDLINE | ID: mdl-38567679

BACKGROUND: Anticoagulation is essential for the treatment and prevention of thromboembolic events. Current guidelines recommend direct oral anticoagulants (DOACs) over vitamin K antagonists in DOAC-eligible patients. The major complication of anticoagulation is serious or life-threatening haemorrhage, which may necessitate prompt haemostatic intervention. Reversal of DOACs may also be required for patients in need of urgent invasive procedures. This guideline from the European Society of Anaesthesiology and Intensive Care (ESAIC) aims to provide evidence-based recommendations and suggestions on how to manage patients on DOACs undergoing urgent or emergency procedures including the treatment of DOAC-induced bleeding. DESIGN: A systematic literature search was performed, examining four drug comparators (dabigatran, rivaroxaban, apixaban, edoxaban) and clinical scenarios ranging from planned to emergency surgery with the outcomes of mortality, haematoma growth and thromboembolic complications. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology was used to assess the methodological quality of the included studies. Consensus on the wording of the recommendations was achieved by a Delphi process. RESULTS: So far, no results from prospective randomised trials comparing two active comparators (e.g. a direct reversal agent and an unspecific haemostatic agent such as prothrombin complex concentrate: PCC) have been published yet and the majority of publications were uncontrolled and observational studies. Thus, the certainty of evidence was assessed to be either low or very low (GRADE C). Thirty-five recommendations and clinical practice statements were developed. During the Delphi process, strong consensus (>90% agreement) was achieved in 97.1% of recommendations and consensus (75 to 90% agreement) in 2.9%. DISCUSSION: DOAC-specific coagulation monitoring may help in patients at risk for elevated DOAC levels, whereas global coagulation tests are not recommended to exclude clinically relevant DOAC levels. In urgent clinical situations, haemostatic treatment using either the direct reversal or nonspecific haemostatic agents should be started without waiting for DOAC level monitoring. DOAC levels above 50 ng ml-1 may be considered clinically relevant necessitating haemostatic treatment before urgent or emergency procedures. Before cardiac surgery under activated factor Xa (FXa) inhibitors, the use of andexanet alfa is not recommended because of inhibition of unfractionated heparin, which is needed for extracorporeal circulation. In the situation of DOAC overdose without bleeding, no haemostatic intervention is suggested, instead measures to eliminate the DOACs should be taken. Due to the lack of published results from comparative prospective, randomised studies, the superiority of reversal treatment strategy vs. a nonspecific haemostatic treatment is unclear for most urgent and emergency procedures and bleeding. Due to the paucity of clinical data, no recommendations for the use of recombinant activated factor VII as a nonspecific haemostatic agent can be given. CONCLUSION: In the clinical scenarios of DOAC intake before urgent procedures and DOAC-induced bleeding, practitioners should evaluate the risk of bleeding of the procedure and the severity of the DOAC-induced bleeding before initiating treatment. Optimal reversal strategy remains to be determined in future trials for most clinical settings.


Hemostatics , Heparin , Humans , Heparin/therapeutic use , Prospective Studies , Hemorrhage/prevention & control , Anticoagulants , Hemostatics/therapeutic use , Administration, Oral
5.
World J Gastroenterol ; 30(15): 2087-2090, 2024 Apr 21.
Article En | MEDLINE | ID: mdl-38681987

Upper gastrointestinal (GI) hemorrhage presents a substantial clinical challenge. Initial management typically involves resuscitation and endoscopy within 24 h, although the benefit of very early endoscopy (< 12 h) for high-risk patients is debated. Treatment goals include stopping acute bleeding, preventing rebleeding, and using a multimodal approach encompassing endoscopic, pharmacological, angiographic, and surgical methods. Pharmacological agents such as vasopressin, prostaglandins, and proton pump inhibitors are effective, but the increase in antithrombotic use has increased GI bleeding morbidity. Endoscopic hemostasis, particularly for nonvariceal bleeding, employs techniques such as electrocoagulation and heater probes, with concerns over tissue injury from monopolar electrocoagulation. Novel methods such as Hemospray and Endoclot show promise in creating mechanical tamponades but have limitations. Currently, the first-line therapy includes thermal probes and hemoclips, with over-the-scope clips emerging for larger ulcer bleeding. The gold probe, combining bipolar electrocoagulation and injection, offers targeted coagulation but has faced device-related issues. Future advancements involve combining techniques and improving endoscopic imaging, with studies exploring combined approaches showing promise. Ongoing research is crucial for developing standardized and effective hemorrhage management strategies.


Gastrointestinal Hemorrhage , Hemostasis, Endoscopic , Humans , Gastrointestinal Hemorrhage/therapy , Gastrointestinal Hemorrhage/diagnosis , Gastrointestinal Hemorrhage/etiology , Hemostasis, Endoscopic/methods , Hemostasis, Endoscopic/instrumentation , Hemostatics/therapeutic use , Electrocoagulation/methods , Treatment Outcome , Endoscopy, Gastrointestinal/methods
8.
Surg Endosc ; 38(5): 2331-2343, 2024 May.
Article En | MEDLINE | ID: mdl-38630180

BACKGROUND: The use of hemostatic agents by general surgeons during abdominal operations is commonplace as an adjunctive measure to minimize risks of postoperative bleeding and its downstream complications. Proper selection of products can be hampered by marginal understanding of their pharmacokinetics and pharmacodynamics. While a variety of hemostatic agents are currently available on the market, the choice of those products is often confusing for surgeons. This paper aims to summarize and compare the available hemostatic products for each clinical indication and to ultimately better guide surgeons in the selection and proper use of hemostatic agents in daily clinical practice. METHODS: We utilized PubMed electronic database and published product information from the respective pharmaceutical companies to collect information on the characteristics of the hemostatic products. RESULTS: All commercially available hemostatic agents in the US are described with a description of their mechanism of action, indications, contraindications, circumstances in which they are best utilized, and expected results. CONCLUSION: Hemostatic products come with many different types and specifications. They are valuable tools to serve as an adjunct to surgical hemostasis. Proper education and knowledge of their characteristics are important for the selection of the right agent and optimal utilization.


Hemostasis, Surgical , Hemostatics , Humans , Hemostatics/therapeutic use , Hemostatics/pharmacology , Hemostasis, Surgical/methods , Postoperative Hemorrhage/prevention & control , Blood Loss, Surgical/prevention & control
9.
Expert Opin Drug Deliv ; 21(3): 457-477, 2024 Mar.
Article En | MEDLINE | ID: mdl-38467560

INTRODUCTION: Immediate control of bleeding and anti-infection play important roles in wound management. Multiple organ dysfunction syndrome and death may occur if persistent bleeding, hemodynamic instability, and hypoxemia are not addressed. The combination of clay and hydrogel provides a new outlet for wound hemostasis. In this review, the current research progress of hydrogel/clay composite hemostatic agents was reviewed. AREAS COVERED: This paper summarizes the characteristics of several kinds of clay including kaolinite, montmorillonite, laponite, sepiolite, and palygorskite. The advantages and disadvantages of its application in hemostasis were also summarized. Future directions for the application of hydrogel/clay composite hemostatic agents are presented. EXPERT OPINION: Clay can activate the endogenous hemostatic pathway by increasing blood cell concentration and promoting plasma absorption to accelerate the hemostasis. Clay is antimicrobial due to the slow release of metal ions and has a rich surface charge with a high affinity for proteins and cells to promote tissue repair. Hydrogels have some properties such as good biocompatibility, strong adhesion, high stretchability, and good self-healing. Despite promising advances, hydrogel/clay composite hemostasis remains a limitation. Therefore, more evidence is needed to further elucidate the risk factors and therapeutic effects of hydrogel/clay in hemostasis and wound healing.


Clay , Hemostasis , Hemostatics , Hydrogels , Wound Healing , Hydrogels/chemistry , Humans , Wound Healing/drug effects , Hemostasis/drug effects , Animals , Hemostatics/pharmacology , Hemostatics/administration & dosage , Hemostatics/therapeutic use , Hemostatics/chemistry , Clay/chemistry , Hemorrhage/drug therapy , Aluminum Silicates/chemistry
11.
Biomaterials ; 307: 122524, 2024 Jun.
Article En | MEDLINE | ID: mdl-38513435

Patients diagnosed with T1a cancer undergo partial nephrectomy to remove the tumors. In the process of removing the tumors, loss of kidney volume is inevitable, and current surgical methods focus solely on hemostasis and wound closure. Here, we developed an implantable form of decellularized extracellular matrix sponge to target both hemostasis and wound healing at the lesion site. A porous form of kidney decellularized matrix was achieved by fabricating a chemically cross-linked cryogel followed by lyophilization. The prepared kidney decellularized extracellular matrix sponge (kdES) was then characterized for features relevant to a hemostasis as well as a biocompatible and degradable biomaterial. Finally, histological evaluations were made after implantation in rat kidney incision model. Both gelatin sponge and kdES displayed excellent hemocompatibility and biocompatibility. However, after a 4-week observation period, kdES exhibited more favorable wound healing results at the lesion site. This suggests a promising potential for kdES as a supportive material in facilitating wound closure during partial nephrectomy surgery. KdES not only achieved rapid hemostasis for managing renal hemorrhage that is comparable to commercial hemostatic sponges, but also demonstrated superior wound healing outcomes.


Hemostatics , Neoplasms , Humans , Rats , Animals , Decellularized Extracellular Matrix , Hemostatics/pharmacology , Hemostatics/therapeutic use , Hemostasis , Wound Healing , Kidney/injuries
12.
Haemophilia ; 30 Suppl 3: 39-44, 2024 Apr.
Article En | MEDLINE | ID: mdl-38481077

INTRODUCTION: Over the last decades progress in haemophilia treatment has been remarkable and prophylaxis with clotting factor concentrates in haemophilia A and B has been established as the standard of care in individuals with haemophilia and a severe bleeding phenotype. Besides clotting factor products with prolonged half-life non-factor therapies were developed which enable prophylaxis via subcutaneous administration. Factor VIIIa mimetics like emicizumab facilitate the coagulation pathway and are used in routine clinical practice for indivdiduals with haemophilia A. Rebalancing therapeutic agents like fitusiran, concizumab, marstacimab and serpin PC block the anticoagulant pathway and clinical trials using these products in individuals with haemophilia A and B are ongoing. AIM AND METHODS: A narrative review to asess the benefits and risks of non-factor therapies taking in to account re-defined haemophilia treatment goals. RESULTS: Prophylaxis for prevention of bleeds using non-factor products by subcutaneous administration is effective and results in reductions of bleeding episodes in individuals with haemophilia A or B with and without inhibitors. The treatment with emicizumab showed tolerable safety both in clinical trials and long-term real-world observations with few thrombotic events. In some clinical trials with rebalancing therapies (fitusiran and concizumab) thrombotic events occurred. Monitoring of the haemostatic function of novel therapies especially with concomitant haemostatic treatment is not yet established. CONCLUSION: With the advent of novel therapeutic agents including factor concentrates with ultra-long half-life and improved FVIIIa mimetics aimed at raising the bar of protection into the non-hemophilic range redefinition of haemophilia treatment goals is eagerly needed.


Antibodies, Bispecific , Hemophilia A , Hemostatics , Humans , Hemophilia A/therapy , Goals , Hemorrhage/etiology , Hemorrhage/prevention & control , Hemorrhage/drug therapy , Blood Coagulation Factors/therapeutic use , Antibodies, Bispecific/therapeutic use , Hemostatics/therapeutic use , Risk Assessment , Factor VIII/adverse effects , Factor VIII/genetics
13.
Haemophilia ; 30 Suppl 3: 95-102, 2024 Apr.
Article En | MEDLINE | ID: mdl-38539060

INTRODUCTION: The advent of therapeutic recombinant factor VIII (FVIII) and factor IX (FIX) protein infusions revolutionized the care of persons with haemophilia in the 1990s. It kicked off an era with the increasing use of prophylactic factor infusions for patients and transformed conversations around the ideal trough activity levels as well as the ultimate goals in tailored, individualized care. Our knowledge surrounding the immunologic basis of inhibitor development and treatment derives from a time when patients were receiving frequent factor infusions and focused on immune tolerance induction following inhibitor development. DISCUSSION: More recently, care was revolutionized again in haemophilia A with the approval of emicizumab, a bispecific antibody mimicking activated FVIII function, to prevent bleeding. The use of emicizumab prophylaxis has resulted in a significantly slower accumulation of factor exposure days and continued effective prophylaxis in the case of inhibitor development. While emicizumab is effective at reducing the frequency of bleeding events in patients with haemophilia A, management of breakthrough bleeds, trauma, and surgeries still requires additional treatment. Ensuring that FVIII is a therapeutic option, particularly for life-threatening bleeding events and major surgeries is critical to optimizing the care of persons with haemophilia A. Other novel non-factor concentrate therapies, including rebalancing agents, will dramatically change the landscape for persons with haemophilia B with inhibitors. CONCLUSION: This review discusses the changing landscape regarding the timing of inhibitor development and management strategies after inhibitor development, stressing the importance of education across the community to continue to vigilantly monitor for inhibitors and be prepared to treat persons with inhibitors.


Antibodies, Bispecific , Hemophilia A , Hemophilia B , Hemostatics , Humans , Hemophilia A/drug therapy , Factor VIII/therapeutic use , Hemophilia B/drug therapy , Hemorrhage/prevention & control , Hemorrhage/drug therapy , Antibodies, Bispecific/pharmacology , Factor IX/therapeutic use , Hemostatics/therapeutic use
14.
Biomater Adv ; 159: 213834, 2024 May.
Article En | MEDLINE | ID: mdl-38518390

The management of bleeding is an important aspect of endoscopic surgery to avoid excessive blood loss and minimize pain. In clinical settings, sprayable hemostatic particles are used for their easy delivery, adaptability to irregular shapes, and rapid hydration. However, conventional hemostatic particles present challenges associated with tissue adhesion. In a previous study, we reported tissue adhesive microparticles (C10-sa-MPs) derived from Alaska pollock gelatin modified with decyl groups (C10-sa-ApGltn) using secondary amines as linkages. The C10-sa-MPs adhere to soft tissues through a hydration mechanism. However, their application as a hemostatic agent was limited by their long hydration times, attributed to their high hydrophobicity. In this study, we present a new type microparticle, C10-am-MPs, synthesized by incorporating decanoyl group modifications into ApGltn (C10-am-ApGltn), using amide bonds as linkages. C10-am-MPs exhibited enhanced hydration characteristics compared to C10-sa-MPs, attributed to superior water absorption facilitated by amide bonds rather than secondary amines. Furthermore, C10-am-MPs demonstrated comparable tissue adhesion properties and underwater adhesion stability to C10-sa-MPs. Notably, C10-am-MPs exhibited accelerated blood coagulation in vitro compared to C10-sa-MPs. The application of C10-am-MPs in an in vivo rat liver hemorrhage model resulted in a hemostatic effect comparable to a commercially available hemostatic particle. These findings highlight the potential utility of C10-am-MPs as an effective hemostatic agent for endoscopic procedures and surgical interventions.


Gadiformes , Hemostatics , Tissue Adhesives , Rats , Animals , Tissue Adhesives/pharmacology , Tissue Adhesives/therapeutic use , Tissue Adhesives/chemistry , Hemostatics/pharmacology , Hemostatics/therapeutic use , Gelatin/pharmacology , Gelatin/chemistry , Alaska , Tissue Adhesions , Amides , Amines
15.
Blood Coagul Fibrinolysis ; 35(3): 124-128, 2024 Apr 01.
Article En | MEDLINE | ID: mdl-38477833

The aim of this study is to evaluate and describe the utilization and safety of 4F-PCC in a nonanticoagulated, surgical patient population at an academic, tertiary care center. This retrospective, single-center chart review evaluated nonanticoagulated adult patients at least 18 years of age who had at least one dose of 4F-PCC administered between 1 January 2017 and 30 September 2022 for a surgical or peri-procedural indication. Hemostatic efficacy following 4F-PCC administration was the primary outcome, assessed by subsequent blood product administration and hemoglobin and hematocrit reduction. Secondary outcomes included an assessment of thrombotic events within 30 days post-4F-PCC administration, in-hospital mortality, and the length of hospital stay. A total of 71 patients met the inclusion criteria, with 61 patients receiving 4F-PCC for cardiac surgery and 10 patients for other intraoperative or peri-procedural indications. The mean total 4F-PCC dose was 25.0 U/kg. For the primary outcome of hemostatic efficacy, 81% of patients had excellent hemostasis; however, blood product administration was reported in 95.8% of patients post-4F-PCC. Thromboembolic events occurred in 10 (14.1%) patients and 21.1% of patients expired prior to discharge in the total cohort. Off-label 4F-PCC use in nonanticoagulated patients is reported despite a lack of robust guidance for use. Following 4F-PCC administration, hemostatic efficacy based on hemoglobin and hematocrit changes was observed; however, blood product use was frequent, and 4F-PCC administration was not without risks, including thromboembolic complications such deep vein thrombosis (DVT), pulmonary embolism, and stroke. Further studies are needed to validate the off-label administration of 4F-PCC in nonanticoagulated patients.


Hemostatics , Thromboembolism , Adult , Humans , Retrospective Studies , Off-Label Use , Blood Coagulation Factors/adverse effects , Factor IX , Hemostatics/therapeutic use , Thromboembolism/chemically induced , Hemoglobins , Anticoagulants/adverse effects
16.
Rinsho Ketsueki ; 65(2): 90-94, 2024.
Article Ja | MEDLINE | ID: mdl-38448004

A 62-year-old woman was diagnosed as a hemophilia A carrier (factor VIII activity 35%) on preoperative examination of an ovarian tumor. A total of 35,600 units of recombinant factor VIII products was administered perioperatively. On postoperative day 95, a subcutaneous hematoma formed and immunosuppressive therapy with prednisolone was started based on an APTT of 66 seconds, factor VIII (FVIII) activity of 3%, and FVIII inhibitor of 1 BU/ml. During this treatment, the patient was hospitalized due to ankle joint bleeds and required hemostatic treatment, but the inhibitor disappeared and FVIII activity recovered to 30% after postoperative day 438 with cyclophosphamide. F8 analysis revealed the patient carried a heterozygosity of p.Arg391Cys, which has previously been categorized as cross-reacting material (CRM)-positive severe hemophilia A. No high-risk mutations for inhibitor development were found. We also report the results of a desmopressin acetate hydrate test administered to the patient to prepare for future treatment in case of hemorrhage, since high-dose FVIII administration may have been a factor in inhibitor development.


Hemophilia A , Hemostatics , Female , Humans , Middle Aged , Factor VIII/therapeutic use , Hemophilia A/drug therapy , Hemostatics/therapeutic use , Hemarthrosis , Immunosuppression Therapy
18.
Am J Obstet Gynecol ; 230(3S): S1089-S1106, 2024 Mar.
Article En | MEDLINE | ID: mdl-38462250

Viscoelastic hemostatic assays are point-of-care devices that assess coagulation and fibrinolysis in whole blood samples. These technologies provide numeric and visual information of clot initiation, clot strength, and clot lysis under low-shear conditions, and have been used in a variety of clinical settings and subpopulations, including trauma, cardiac surgery, and obstetrics. Emerging data indicate that these devices are useful for detecting important coagulation defects during major postpartum hemorrhage (especially low plasma fibrinogen concentration [hypofibrinogenemia]) and informing clinical decision-making for blood product use. Data from observational studies suggest that, compared with traditional formulaic approaches to transfusion management, targeted or goal-directed transfusion approaches using data from viscoelastic hemostatic assays are associated with reduced hemorrhage-related morbidity and lower blood product requirement. Viscoelastic hemostatic assays can also be used to identify and treat coagulation defects in patients with inherited or acquired coagulation disorders, such as factor XI deficiency or immune-mediated thrombocytopenia, and to assess hemostatic profiles of patients prescribed anticoagulant medications to mitigate the risk of epidural hematoma after neuraxial anesthesia and postpartum hemorrhage after delivery.


Blood Coagulation Disorders , Hemostatics , Postpartum Hemorrhage , Pregnancy , Female , Humans , Hemostatics/therapeutic use , Postpartum Hemorrhage/diagnosis , Postpartum Hemorrhage/therapy , Thrombelastography , Hemostasis , Blood Coagulation , Blood Coagulation Disorders/diagnosis , Blood Coagulation Disorders/therapy
19.
Cardiol Rev ; 32(3): 194-202, 2024.
Article En | MEDLINE | ID: mdl-38517253

Intracerebral hemorrhage (ICH) is the second most common type of stroke, accounting for approximately 10-20% of all strokes, and is linked to severe neurological disability and death. Since the most accurate predictor of outcome in patients with ICH is hematoma volume, there is a great need for pharmacologic therapy that can reduce hematoma expansion and resultant mass effect and edema. This is especially critical within the ultra-early window of 3-4 hours after the presentation. Hemostatic therapies are exceptionally important for those patients taking antiplatelet or anticoagulant medications to reverse the effects of these medications and therefore prevent hematoma expansion. Furthermore, the recent publication of the 2023 Guideline for the Management of Patients with Aneurysmal Subarachnoid Hemorrhage by the American Heart Association/American Stroke Association, the first update to the guidelines since 2012, underscores the importance of optimizing anticoagulation reversal for this population. The purpose of this selective, nonsystematic review is to examine current literature regarding the use of hemostatic therapies in ICH, with particular attention paid to antiplatelet, anticoagulation, and antifibrinolytic therapies.


Hemostatics , Stroke , Subarachnoid Hemorrhage , Humans , Hemostatics/therapeutic use , Cerebral Hemorrhage/therapy , Stroke/drug therapy , Hematoma
20.
Int J Biol Macromol ; 264(Pt 2): 130771, 2024 Apr.
Article En | MEDLINE | ID: mdl-38467220

Development of the efficient hemostatic materials is an essential requirement for the management of hemorrhage caused by the emergency situations to avert most of the casualties. Such injuries require the use of external hemostats to facilitate the immediate blood clotting. A variety of commercially available hemostats are present in the market but most of them are associated with limitations such as exothermic reactions, low biocompatibility, and painful removal. Thus, fabrication of an ideal hemostatic composition for rapid blood clot formation, biocompatibility, and antimicrobial nature presents a real challenge to the bioengineers. Benefiting from their tunable fabrication properties, alginate-based hemostats are gaining importance due to their excellent biocompatibility, with >85 % cell viability, high absorption capacity exceeding 500 %, and cost-effectiveness. Furthermore, studies have estimated that wounds treated with sodium alginate exhibited a blood loss of 0.40 ± 0.05 mL, compared to the control group with 1.15 ± 0.13 mL, indicating its inherent hemostatic activity. This serves as a solid foundation for designing future hemostatic materials. Nevertheless, various combinations have been explored to further enhance the hemostatic potential of sodium alginate. In this review, we have discussed the possible role of alginate based composite hemostats incorporated with different hemostatic agents, such as inorganic materials, polymers, biological agents, herbal agents, and synthetic drugs. This article outlines the challenges which need to be addressed before the clinical trials and give an overview of the future research directions.


Hemostatics , Thrombosis , Humans , Hemostatics/pharmacology , Hemostatics/therapeutic use , Biocompatible Materials/pharmacology , Biocompatible Materials/therapeutic use , Alginates/pharmacology , Hemostasis , Blood Coagulation , Hemorrhage/drug therapy
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