- MeSH
- antifibrinolytika farmakologie klasifikace terapeutické užití MeSH
- chemicky indukované poruchy * etiologie klasifikace krev MeSH
- farmakoterapie klasifikace MeSH
- hemostatika farmakologie klasifikace terapeutické užití MeSH
- lidé MeSH
- nežádoucí účinky léčiv krev MeSH
- počet trombocytů MeSH
- receptory thrombopoetinu antagonisté a inhibitory MeSH
- trombocytopenie * chemicky indukované diagnóza etiologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared with intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis, when 75% of anticipated participants had completed follow up, the data and safety monitoring board recommended to terminate the trial, and upon unblinding, the operations committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group, and 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5% [95% CI, -0.9 to 0.03]; P=0.07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3% [95% CI, 5.2-11.5]; P=0.007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared with the intravenous group was 8.2% (95% CI, 3.4-12.9). CONCLUSIONS: Among patients undergoing cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared with intravenous tranexamic acid. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03954314.
- MeSH
- antifibrinolytika * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- aplikace lokální * MeSH
- dvojitá slepá metoda MeSH
- intravenózní podání * MeSH
- kardiochirurgické výkony * škodlivé účinky MeSH
- krvácení při operaci prevence a kontrola MeSH
- kyselina tranexamová * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- výsledek terapie MeSH
- záchvaty prevence a kontrola etiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Congenital fibrinogen deficiency (CFD) is a rare bleeding disorder caused by mutations in FGA, FGB, and FGG. We sought to comprehensively characterize patients with CFD using PRO-RBDD (Prospective Rare Bleeding Disorders Database). Clinical phenotypes, laboratory, and genetic features were investigated using retrospective data from the PRO-RBDD. Patients were classified from asymptomatic to grade 3 based on their bleeding severity. In addition, FGA, FGB, and FGG were sequenced to find causative variants. A total of 166 CFD cases from 16 countries were included, of whom 123 (30 afibrinogenemia, 33 hypofibrinogenemia, 55 dysfibrinogenemia, and 5 hypodysfibrinogenemia) were well characterized. Considering the previously established factor activity and antigen level thresholds, bleeding severity was correctly identified in 58% of the cases. The rates of thrombotic events among afibrinogenemic and hypofibrinogenemic patients were relatively similar (11% and 10%, respectively) and surprisingly higher than in dysfibrinogenemic cases. The rate of spontaneous abortions among 68 pregnancies was 31%, including 86% in dysfibrinogenemic women and 14% with hypofibrinogenemia. Eighty-six patients received treatment (69 on-demand and/or 17 on prophylaxis), with fibrinogen concentrates being the most frequently used product. Genetic analysis was available for 91 cases and 41 distinct variants were identified. Hotspot variants (FGG, p.Arg301Cys/His and FGA, p.Arg35Cys/His) were present in 51% of dysfibrinogenemia. Obstetric complications were commonly observed in dysfibrinogenemia. This large multicenter study provided a comprehensive insight into the clinical, laboratory, and genetic history of patients with CFDs. We conclude that bleeding severity grades were in agreement with the established factor activity threshold in nearly half of the cases with quantitative defects.
Život ohrožující krvácení je jedním z nejzávažnějších akutních stavů v medicíně. Tato situace vyžaduje multimodální terapii, jejíž nedílnou součástí je i podávání transfuzních přípravků a krevních derivátů, které bývá standardizováno pomocí doporučených postupů. Pro Českou republiku a Slovensko je v současnosti platný dokument „Diagnostika a léčba život ohrožujícího krvácení u dospělých pacientů v intenzivní a perioperační péči. Česko-slovenský mezioborový doporučený postup“ z roku 2017. V roce 2023 byl publikován update obou evropských doporučení, ze kterých zmíněný mezioborový postup majoritně vychází. Cílem této práce je identifikovat a představit změny v evropských doporučených postupech pro život ohrožující krvácení, které se objevily od roku 2017. Celkem jsou zahrnuty 4 texty, jejichž analýza je rozčleněna dle jednotlivých transfuzních přípravků a krevních derivátů. Samotný text práce nabízí kromě představení nových evropských doporučených postupů pro léčbu život ohrožujícího krvácení také jejich srovnání s česko-slovenským postupem z roku 2017.
Major bleeding is one of the most serious emergencies in medicine. This situation requires a complex therapeutic approach, including standardised administering transfusion products and blood derivatives. In the Czech Republic and Slovakia, the document “Diagnosis and Treatment of Life-Threatening Bleeding in Adult Patients in Intensive and Perioperative Care. Czech-Slovak Interdisciplinary Guideline” from 2017 remains valid. In 2023, an update of both European guidelines, from which the mentioned interdisciplinary procedure predominantly derives, was published. This work aims to identify and present changes in the European guidelines for severe bleeding since 2017. A total of 4 texts are included. Their analysis was divided according to individual transfusion products and blood derivatives. This work not only presents the new European guidelines for treating severe bleeding, but also compares these with the Czech-Slovak guideline from 2017.
- MeSH
- antifibrinolytika farmakologie terapeutické užití MeSH
- faktor VIII farmakologie terapeutické užití MeSH
- fibrinogen farmakologie terapeutické užití MeSH
- krevní plazma MeSH
- krevní transfuze metody MeSH
- krvácení * terapie MeSH
- lidé MeSH
- protrombin farmakologie terapeutické užití MeSH
- směrnice pro lékařskou praxi jako téma MeSH
- transfuze erytrocytů metody MeSH
- transfuze trombocytů metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- MeSH
- antifibrinolytika terapeutické užití MeSH
- anxiolytika terapeutické užití MeSH
- dítě MeSH
- dyspnoe etiologie farmakoterapie psychologie MeSH
- hemoptýza etiologie terapie MeSH
- kašel farmakoterapie MeSH
- lidé MeSH
- opioidní analgetika terapeutické užití MeSH
- oxygenoterapie metody MeSH
- paliativní péče * metody MeSH
- polohování pacienta MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- Publikační typ
- přehledy MeSH
PURPOSE OF THE STUDY This study aims to analyse a subpopulation of patients with severe haemorrhagic shock and a concurrent unstable pelvic ring fracture. MATERIAL AND METHODS This manuscript is a retrospective study of prospectively collected data on trauma patients over a period of 10 years, namely between 2010 and 2019. These patients, primarily (after injury) referred to the trauma centre of the University Hospital Hradec Králové, were diagnosed with an unstable pelvic ring fracture as a part of multiple injuries. RESULTS The total number of patients with a pelvic ring fracture and concurrent acute phase of decompensated haemorrhagic shock in the period from 2010 to 2019 was 112. After excluding 25 patients with AIS 4 and 5 (Abbreviated Injury Scale) severe head trauma and another two patients who died of late-stage SIRS (systemic infl ammatory response syndrome) complications, the group consisted of 85 patients. Subsequently, the subpopulation of patients "in extremis" evaluated by the study included a total of 22 patients with the baseline systolic pressure below 70 mm Hg and/or baseline haemoglobin level below 80 g/l. CONCLUSIONS Prior to the evaluation of this study population, our department had no single algorithm developed to treat such patients. Slow blood circulation stabilisation or death were usually associated with inadequate haemostatic algorithm. The patients leaving the operating room and being handed over to the ICU presented the signs of a decompensated shock. Oftentimes, the pelvis was merely stabilised, with no further intervention to stop the bleeding. The extraperitoneal pelvic packing was performed in very few cases only. The extravasation of contrast media during the initial CT scan does not necessarily have to be detected due to vasospasm or hypotension with reduced blood fl ow. In such cases, only the size of haematoma is a sign of arterial bleeding. It is also risky to rely solely on vasography when stopping the bleeding which will certainly fail to stop venous bleeding. However, venous bleeding always accompanies arterial bleeding. Stabilisation of both segments of the pelvis is essential to stop bleeding in haemodynamically unstable patients with a pelvic ring injury. It is followed by extraperitoneal pelvic packing and in the case of continuing haemodynamic instability also vasography, namely even if there is a negative fi nding of the initial CT scan or if no initial CT scan was performed. This procedure has become the core of our single haemostatic algorithm. Key words: pelvic ring injury, patients in extremis, haemostatic algorithm.
Postpartum haemorrhage (PPH) remains the leading cause of pregnancy-related deaths worldwide. Typically, bleeding is controlled by timely obstetric measures in parallel with resuscitation and treatment of coagulopathy. Early recognition of abnormal coagulation is crucial and haemostatic support should be considered simultaneously with other strategies as coagulopathies contribute to the progression to massive haemorrhage. However, there is lack of agreement on important topics in the current guidelines for management of PPH. A clinical definition of PPH is paramount to understand the situation to which the treatment recommendations relate; however, reaching a consensus has previously proven difficult. Traditional definitions are based on volume of blood loss, which is difficult to monitor, can be misleading and leads to treatment delay. A multidisciplinary approach to define PPH considering vital signs, clinical symptoms, coagulation and haemodynamic changes is needed. Moreover, standardised algorithms or massive haemorrhage protocols should be developed to reduce the risk of morbidity and mortality and improve overall clinical outcomes in PPH. If available, point-of-care testing should be used to guide goal-directed haemostatic treatment. Tranexamic acid should be administered as soon as abnormal bleeding is recognised. Fibrinogen concentrate rather than fresh frozen plasma should be administered to restore haemostasis where there is elevated risk of fibrinogen deficiency (e.g., in catastrophic bleeding or in cases of abruption or amniotic fluid embolism) as it is a more concentrated source of fibrinogen. Lastly, organisational considerations are equally as important as clinical interventions in the management of PPH and have the potential to improve patient outcomes.
- MeSH
- fibrinogen MeSH
- hemostatika * terapeutické užití MeSH
- lidé MeSH
- poporodní krvácení * diagnóza terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
OBJECTIVES: Degradation of coagulation proteins in frozen plasma may influence assay results. The aims of this study were to explore the changes in coagulation parameters in patient plasma and internal quality control (IQC) after different freezing and storage conditions during the short-term and long-term periods. METHODS: Platelet poor plasma was prepared from citrated peripheral blood collected from a group of healthy donors. The plasma was pooled, frozen and stored in a variety of freezing and storage conditions. The changes were monitored using routine coagulation assays, as well as factor VIII (FVIII) and protein S (PS) assays. RESULTS: Plasma stored in liquid nitrogen (LN 2 ) or in -80°C showed long-term stable values for routine tests for a period of over 12 months, and 6 months for FVIII. Interestingly, the activated partial thromboplastin time (aPTT) showed a temporary significant prolongation over the first two weeks. Plasma frozen and stored in -40°C is not viable for aPTT and FVIII testing, otherwise it can be used for other parameters for up to 4 months. PS showed a significant increase in all frozen samples. Freezing rate has a significant impact on plasma quality and the final storage temperature influences the long-term stability. CONCLUSION: The optimal storage conditions are ultra-low temperatures (LN 2 or -80°C) and the highest freezing rate possible. However, frozen plasma is not viable for IQC of aPTT during a period of two weeks after freezing. This study is unique in its conception as a practical guide for the handling of frozen plasma samples in modern laboratory settings.
- MeSH
- hemokoagulace MeSH
- hemostatika * MeSH
- krevní plazma * MeSH
- lidé MeSH
- parciální tromboplastinový čas MeSH
- vyšetření krevní srážlivosti MeSH
- zmrazování MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Factor VIII (FVIII) inhibitor formation is a major clinical concern during replacement therapy in patients with hemophilia A. Immune tolerance induction (ITI) is the only therapeutic approach to attempt inhibitor eradication and establishment of long-term immune tolerance to FVIII. Hemophilia Inhibitor Previously Untreated Patient (PUP) Study (HIPS) was a prospective clinical trial to investigate changes in the immune system of PUPs with severe hemophilia A. Five patients who developed persistent FVIII inhibitors during HIPS entered an ITI extension arm (HIPS-ITI). During HIPS-ITI, inhibitor patients received ITI with the same FVIII product (a single source of recombinant, human full-length FVIII) used in HIPS until successful tolerance, declared failure, or a maximum of 2 years after HIPS-ITI enrollment, whichever came first. Blood samples and clinical data were collected monthly. Longitudinal FVIII-binding antibody signatures, associated binding specificities, and apparent affinities were determined for each patient at each sampling time point. ITI was successful or partially successful in 2 patients and failed in 3. Both groups presented with distinct FVIII-specific antibody signatures. ITI success required the disappearance of FVIII inhibitors, which was associated with the eradication or sustained titer minimization of high-affinity FVIII-specific antibodies, particularly of the immunoglobulin G1 (IgG1) and IgG4 subclasses. In contrast, ITI failure, as reflected by FVIII inhibitor persistence, was associated with persistent high-affinity FVIII-specific antibodies. Interestingly, 1 patient with partial ITI success and 1 patient with ITI failure developed apparent oligoreactive FVIII-binding antibodies during ITI. The explanation of the true nature of these antibodies requires more comprehensive follow-ups in future studies. This trial was registered at www.clinicaltrials.gov as #NCT01652027.
PURPOSE OF THE STUDY Tranexamic acid as a haemostatic agent is commonly used in multiple medical branches. Over the last decade, there has been a steep rise in the number of studies evaluating its effect, i.e. blood loss reduction in specific surgical procedures. The aim of our study was to evaluate the effect of tranexamic acid on reducing intraoperative blood loss, postoperative blood loss into the drain, total blood loss, transfusion requirements, and development of symptomatic wound hematoma in conventional single-level lumbar decompression and stabilization. MATERIAL AND METHODS The study included patients who had undergone a traditional open lumbar spine surgery in the form of single-level decompression and stabilisation. The patients were randomized into two groups. The study group received a 15 mg/kg dose of tranexamic acid intravenously during the induction of anaesthesia and then again 6 hours later. No tranexamic acid was administered to the control group. In all patients, intraoperative blood loss, postoperative blood loss into the drain, and therefore also total blood loss, transfusion requirements and potential development of a symptomatic postoperative wound hematoma requiring surgical evacuation were recorded. The data of the two groups were compared. RESULTS The cohort includes 162 patients, 81 in the study group and the same number in the control group. In the intraoperative blood loss assessment, no statistically significant difference between the two groups was observed; 430 (190-910) mL vs. 435 (200-900) mL. In case of post-operative drain blood loss, a statistically significantly lower volume was reported after the tranexamic acid administration; 405 (180-750) mL vs. 490 (210-820) mL. When evaluating the total blood loss, a statistically significant difference was also confirmed, namely in favour of the tranexamic acid; 860 (470-1410) mL vs. 910 (500- 1420) mL. The reduction of total blood loss did not result in a difference in the number of administered transfusions; transfusions were given to 4 patients in each group. A postoperative wound hematoma requiring surgical evacuation developed in 1 patient in the group with the tranexamic acid and in 4 patients in the control group, but the difference was not statistically significant with respect to the insufficient group size. No patient in our study experienced complications associated with tranexamic acid application. DISCUSSION The beneficial effect of tranexamic acid on reducing blood loss in lumbar spine surgeries has already been confirmed by numerous meta-analyses. The question remains in what types of procedures, at what dose and route of administration its effect is significant. To date, most of the studies have explored its effect in multi-level decompressions and stabilizations. Raksakietisak et al., for instance, report significant reduction in total blood loss from 900 (160, 4150) mL to 600 (200, 4750) mL following an intravenous injection of 2 bolus doses of 15 mg/kg tranexamic acid. In less extensive spinal surgeries, the effect of tranexamic acid may not be that distinct. In our study of single-level decompressions and stabilizations, no reduction in the actual intraoperative bleeding was confirmed at the given dosage. Its effect was seen only in the postoperative period in a significant reduction of blood loss into the drain, thus also in the total blood loss, although the difference between 910 (500, 1420) mL and 860 (470, 1410) mL was not that significant. CONCLUSIONS By intravenous application of tranexamic acid in 2 bolus doses in single-level decompression and stabilization of the lumbar spine a statistically significant reduction in postoperative blood loss into the drain and also total blood loss was confirmed. The reduction in the actual intraoperative blood loss was not statistically significant. No difference was observed in the number of administered transfusions. Following the tranexamic acid administration, a lower number of postoperative symptomatic wound hematomas was recorded, but the difference was not statistically significant. Key words: tranexamic acid, spinal surgeries, blood loss, postoperative hematoma.
- MeSH
- antifibrinolytika * MeSH
- hematom prevence a kontrola MeSH
- krvácení při operaci prevence a kontrola MeSH
- kyselina tranexamová * MeSH
- lidé MeSH
- pooperační krvácení prevence a kontrola farmakoterapie MeSH
- prospektivní studie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- anglický abstrakt MeSH
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
