[Peripartum hemorrhage, diagnostics and treatment : Update of the S2k guidelines AWMF 015/063 from August 2022]. / Peripartale Blutungen, Diagnostik und Therapie : Update der S2k-Leitlinie AWMF 015/063 vom August 2022.

The current S2k guidelines on the diagnostics and treatment of peripartum hemorrhage are summarized in this article from the perspective of anesthesiology based on a fictitious case report. The update of the guidelines was written under the auspices of the German Society of Gynecology and Obstetrics with the participation of other professional societies and interest groups from Germany, Austria and Switzerland and published by the AWMF in 2022 under the register number 015/063.

A European consensus statement on the use of four-factor prothrombin complex concentrate for cardiac and non-cardiac surgical patients.

Modern four-factor prothrombin complex concentrate was designed originally for rapid targeted replacement of the coagulation factors II, VII, IX and X. Dosing strategies for the approved indication of vitamin K antagonist-related bleeding vary greatly. They include INR and bodyweight-related protocols as well as fixed dose regimens. Particularly in the massively bleeding trauma and cardiac surgery patient, four-factor prothrombin complex concentrate is used increasingly for haemostatic resuscitation. Members of the Transfusion and Haemostasis Subcommittee of the European Association of Cardiothoracic Anaesthesiology performed a systematic literature review on four-factor prothrombin complex concentrate. The available evidence has been summarised for dosing, efficacy, drug safety and monitoring strategies in different scenarios. Whereas there is evidence for the efficacy of four-factor prothrombin concentrate for a variety of bleeding scenarios, convincing safety data are clearly missing. In the massively bleeding patient with coagulopathy, our group recommends the administration of an initial bolus of 25 IU.kg-1 . This applies for: the acute reversal of vitamin K antagonist therapy; haemostatic resuscitation, particularly in trauma; and the reversal of direct oral anticoagulants when no specific antidote is available. In patients with a high risk for thromboembolic complications, e.g. cardiac surgery, the administration of an initial half-dose bolus (12.5 IU.kg-1 ) should be considered. A second bolus may be indicated if coagulopathy and microvascular bleeding persists and other reasons for bleeding are largely ruled out. Tissue-factor-activated, factor VII-dependent and heparin insensitive point-of-care tests may be used for peri-operative monitoring and guiding of prothrombin complex concentrate therapy.

Elderly patients with atrial fibrillation in routine clinical practice-peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study.

BACKGROUND: Annually > 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated. METHODS: Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality. RESULTS: Of the 1442 patients, 280 (19%) were < 65, 550 (38%) were 65-74, 514 (36%) 75-84, and 98 (7%) were 85 years old or older. With increasing age, comorbidities and risk scores were higher. Any bleeding complications were uncommon across all ages, ranging from 3.9% in patients < 65 to 4.1% in those 85 years or older; major bleeding rates in any age group were ≤ 0.6%. Interruption rates and duration increased with advancing age. Thromboembolic events were more common in the elderly, with all nine events occurring in those > 65, and seven in patients aged > 75 years. CONCLUSION: Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed. TRIAL REGISTRATION: NCT# 02950168, October 31, 2016.

[Postdural puncture headache after neuraxial anesthesia: incidence and risk factors]. / Postpunktioneller Kopfschmerz nach rückenmarknahen Anästhesieverfahren: Inzidenz und Risikofaktoren.

BACKGROUND/OBJECTIVE: Postdural puncture headache (PDPH) is a severe complication after spinal anesthesia. The aim of this study was to investigate the incidence of PDPH in two different operative cohorts and to identify risk factors for its occurrence as well as to analyze its influence on the duration of hospital stay. MATERIAL AND METHODS: In a retrospective study over a period of 3 years (2010-2012), 341 orthopedic surgery (ORT) and 2113 obstetric (OBS) patients were evaluated after spinal anesthesia (SPA). Data were statistically analyzed using (SPSS-23) univariate analyses with the Mann-Whitney U­test, χ2-test and Student's t-test as well as logistic regression analysis. RESULTS: The incidence of PDPH was 5.9% in the ORT cohort and 1.8% in the OBS cohort. Patients with PDPH in the ORT cohort were significantly younger (median 38 years vs. 47 years, p = 0.011), had a lower body weight (median 70.5 kg vs. 77 kg, p = 0.006) and a lower body mass index (median 23.5 vs. 25.2, p = 0.037). Body weight (odds ratio (97.5 % Confidence Intervall [CI]), OR 0.956: 97.5% CI 0.920-0.989, p = 0.014) as well as age (OR 0.963: 97.5% CI 0.932-0.991, p = 0.015) were identified as independent risk factors for PDPH. In OBS patients, PDPH occurred more frequently after spinal epidural anesthesia than after combined spinal epidural anesthesia (8.6% vs. 1.2%, p < 0.001) and the type of neuraxial anesthesia was identified as an independent risk factor for PDPH (OR 0.049; 97.5% CI 0.023-0.106, p < 0.001). In both groups the incidence of PDPH was associated with a longer hospital stay (ORT patients 4 days vs. 2 days, p = 0.001; OBS patients 6 days vs. 4 days, p < 0.0005). CONCLUSION: The incidence of PDPH was different in the two groups with a higher incidence in the ORT but considerably lower than in the literature. Age, constitution and type of neuraxial anesthesia were identified as risk factors of PDPH. Considering the functional imitations (mobilization, neonatal care) and a longer hospital stay, future studies should investigate the impact of an early treatment of PDPH.

The role of fibrinogen and fibrinogen concentrate in cardiac surgery: an international consensus statement from the Haemostasis and Transfusion Scientific Subcommittee of the European Association of Cardiothoracic Anaesthesiology.

To date, data regarding the efficacy and safety of administering fibrinogen concentrate in cardiac surgery are limited. Studies are limited by their low sample size and large heterogeneity with regard to the patient population, by the timing of fibrinogen concentrate administration, and by the definition of transfusion trigger and target levels. Assessment of fibrinogen activity using viscoelastic point-of-care testing shortly before or after weaning from cardiopulmonary bypass in patients and procedures with a high risk of bleeding appears to be a rational strategy. In contrast, the use of Clauss fibrinogen test for determination of plasma fibrinogen level can no longer be recommended without restrictions due to its long turnaround time, high inter-assay variability and interference with high heparin levels and fibrin degradation products. Administration of fibrinogen concentrate for maintaining physiological fibrinogen activity in the case of microvascular post-cardiopulmonary bypass bleeding appears to be indicated. The available evidence does not suggest aiming for supranormal levels, however. Use of cryoprecipitate as an alternative to fibrinogen concentrate might be considered to increase plasma fibrinogen levels. Although conclusive evidence is lacking, fibrinogen concentrate does not seem to increase adverse outcomes (i.e., thromboembolic events). Large prospective multi-centre studies are needed to better define the optimal perioperative monitoring tool, transfusion trigger and target levels for fibrinogen replacement in cardiac surgery.

Impact of brief prewarming on anesthesia-related core-temperature drop, hemodynamics, microperfusion and postoperative ventilation in cytoreductive surgery of ovarian cancer: a randomized trial.

BACKGROUND: General (GA)- and epidural-anesthesia may cause a drop in body-core-temperature (BCTdrop), and hypothermia, which may alter tissue oxygenation (StO2) and microperfusion after cytoreductive surgery for ovarian cancer. Cell metabolism of subcutaneous fat- or skeletal muscle cells, measured in microdialysis, may be affected. We hypothesized that forced-air prewarming during epidural catheter placement and induction of GA maintains normothermia and improves microperfusion. METHODS: After ethics approval 47 women scheduled for cytoreductive surgery were prospectively enrolled. Women in the study group were treated with a prewarming of 43 °C during epidural catheter placement. BCT (Spot on®, 3 M) was measured before (T1), after induction of GA (T2) at 15 min (T3) after start of surgery, and until 2 h after ICU admission (TICU2h). Primary endpoint was BCTdrop between T1 and T2. Microperfusion-, hemodynamic- and clinical outcomes were defined as secondary outcomes. Statistical analysis used the Mann-Whitney-U- and non-parametric-longitudinal tests. RESULTS: BCTdrop was 0.35 °C with prewarming and 0.9 °C without prewarming (p < 0.005) and BCT remained higher over the observation period (ΔT4 = 0.9 °C up to ΔT7 = 0.95 °C, p < 0.001). No significant differences in hemodynamic parameters, transfusion, arterial lactate and dCO2 were measured. In microdialysis the ethanol ratio was temporarily, but not significantly, reduced after prewarming. Lactate, glucose and glycerol after PW tended to be more constant over the entire period. Postoperatively, six women without prewarming, but none after prewarming were mechanical ventilated (p < 0.001). CONCLUSION: Prewarming at 43 °C reduces the BCTdrop and maintains normothermia without impeding the perioperative routine patient flow. Microdialysis indicate better preserved parameters of microperfusion. TRIAL REGISTRATION: ClinicalTrials.gov ; ID: NCT02364219 ; Date of registration: 18-febr-2015.

[Diagnostics and treatment of preoperative anemia]. / Diagnostik und Behandlung der präoperativen Anämie.

Approximately 14-40% of patients in industrialized countries present with preoperative anemia. Depending on the severity, anemia is associates with increased perioperative morbidity and mortality. One of the most important causes of preoperative anemia is iron deficiency which is usually easy to treat. Implemented in the multimodal concept of patient blood management, the diagnostics and treatment of preoperative anemia are important aspects for improvement of perioperative outcome. Adequate and early diagnostics of the cause of anemia before treatment is important because treatment options, e.g. with iron, erythropoetin, folic acid and vitamin B12, may be expensive, may have severe side effects, and in the case of a wrong indication, will not improve anemia. In addition, an adequate regeneration of the erythrocyte volume requires time. This review article presents important aspects of the epidemiology and prognostic implications of preoperative anemia, the physiology and pathophysiology of anemia as well as diagnostic features and the evidence base for preoperative treatment options.

Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study.

BACKGROUND: Adult cardiac surgery is often complicated by elevated blood losses that account for elevated transfusion requirements. Perioperative bleeding and transfusion of blood products are major risk factors for morbidity and mortality. Timely diagnostic and goal-directed therapies aim at the reduction of bleeding and need for allogeneic transfusions. METHODS: Single-centre, prospective, randomized trial assessing blood loss and transfusion requirements of 26 adult patients undergoing elective cardiac surgery at high risk for perioperative bleeding. Primary endpoint was blood loss at 24 h postoperatively. Random assignment to intra- and postoperative haemostatic management following either an algorithm based on conventional coagulation assays (conventional group: platelet count, aPTT, PT, fibrinogen) or based on point-of-care (PoC-group) monitoring, i.e. activated rotational thromboelastometry (ROTEM®) combined with multiple aggregometry (Multiplate®). Differences between groups were analysed using nonparametric tests for independent samples. RESULTS: The study was terminated after interim analysis (n = 26). Chest tube drainage volume was 360 ml (IQR 229-599 ml) in the conventional group, and 380 ml (IQR 310-590 ml) in the PoC-group (p = 0.767) after 24 h. Basic patient characteristics, results of PoC coagulation assays, and transfusion requirements of red blood cells and fresh frozen plasma did not differ between groups. Coagulation results were comparable. Platelets were transfused in the PoC group only. CONCLUSION: Blood loss via chest tube drainage and transfusion amounts were not different comparing PoC- and central lab-driven transfusion algorithms in subjects that underwent high-risk cardiac surgery. Routine PoC coagulation diagnostics do not seem to be beneficial when actual blood loss is low. High risk procedures might not suffice as a sole risk factor for increased blood loss. TRIAL REGISTRATION: NCT01402739 , Date of registration July 26, 2011.

Crystalloid coloading vs. colloid coloading in elective Caesarean section: postspinal hypotension and vasopressor consumption, a prospective, observational clinical trial.

BACKGROUND: Maternal hypotension is a common side effect of spinal anaesthesia for Caesarean section. The combination of colloid coloading and vasopressors was considered our standard for its prevention and treatment. As the safety of hydroxyethyl starch is under debate, we replaced colloid with crystalloid coloading. OBJECTIVE: We hypothesize that the mean blood pressure drop is greater when coloading with crystalloids. DESIGN: Prospective, observational clinical trial. SETTING: Two-centre study conducted in Berlin, Germany. PATIENTS: Parturients scheduled for a Caesarean section were screened for eligibility. INTERVENTION: The study protocol and patient monitoring were based on the standard operating procedure for Caesarean section in both centres. The data from the crystalloid group were prospectively collected between November 2014 and July 2015. MAIN OUTCOME MEASURES: The primary endpoint was the median drop in mean blood pressure after induction of spinal anaesthesia. Secondary endpoints were incidence of hypotension (drop > 20% of baseline systolic pressure /drop < 100 mmHg), vasopressor and additional fluid requirements (mL), incidence of bradycardia (heart rate < 60 beats per minute), blood loss, Apgar score, and umbilical artery pH. In case of hypotension, patients received phenylephrine or cafedrine/theodrenaline according to their heart rate. A p < 0.05 was considered significant. RESULTS: 345 prospectively enrolled patients (n = 193 crystalloid group vs. n = 152 colloid group) were analysed. The median drop in mean blood pressure was greater in the crystalloid group [34 mmHg (25; 42 mmHg) vs. 21 mmHg (13; 29 mmHg), p < 0.001]. Incidences of hypotension [93.3% vs. 83.6%, p: 0.004] and bradycardia [19.7% vs. 9.9%, p: 0.012] were also significantly greater in the crystalloid group. Vasopressor requirements, blood loss and neonatal outcome were not different between the groups. CONCLUSIONS: Crystalloid coloading was associated with a greater drop in mean blood pressure and a higher incidence of hypotension when compared with colloid coloading. Neonatal outcome was, however, unaffected by the type of fluid. TRIAL REGISTRATION: DRKS00006783 ( http://www.drks.de ).

International consensus statement on the peri-operative management of direct oral anticoagulants in cardiac surgery.

Despite current recommendations on the management of severe peri-operative bleeding, there is no pragmatic guidance for the peri-operative monitoring and management of cardiac surgical patients taking direct oral anticoagulants. Members of the Transfusion and Haemostasis Subcommittee of the European Association of Cardiothoracic Anaesthesiology, of their own volition, performed an independent systematic review of peer-reviewed original research, review articles and case reports and developed the following consensus statement. This has been endorsed by the European Association of Cardiothoracic Anaesthesiology. In our opinion, most patients on direct oral anticoagulant therapy presenting for elective cardiac surgery can be safely managed in the peri-operative period if the following conditions are fulfilled: direct oral anticoagulants have been discontinued two days before cardiac surgery, corresponding to five elimination half-live periods; in patients with renal or hepatic impairment or a high risk of bleeding, a pre-operative plasma level of direct oral anticoagulants has been determined and found to be below 30 ng.ml-1 (currently only valid for dabigatran, rivaroxaban and apixaban). In cases where plasma level monitoring is not possible (e.g. assay was not available), discontinuation for 10 elimination half-live periods (four days) is required. For FXa inhibitors, a standard heparin-calibrated anti-Xa level of < 0.1 IU.ml-1 should be measured, indicating sufficient reduction in the anticoagulant effect. Finally, short-term bridging with heparin is not required in the pre-operative period.

[Haemostatic management in postpartum haemorrhage : Nationwide survey in Germany]. / Gerinnungstherapie der peripartalen Hämorrhagie : Deutschlandweite Umfrage.

BACKGROUND: In order to ensure evidence-based haemostatic management of postpartum haemorrhage (PPH, blood loss >500 ml) consistent with guidelines appropriate structural conditions must be fulfilled regardless of different levels (1-3) in perinatal care. The aim of the survey was to identify differences in haemostatic management in PPH under consideration of the different levels of perinatal care in Germany. MATERIALS AND METHODS: An electronic questionnaire assessing the structural and therapeutic preconditions for haemostatic management was sent to 533 anaesthesiology departments serving obstetric units. RESULTS: A total of 156 (29 %) questionnaires returned from hospitals of all levels were analysed. PPH occur in all and increase with higher level hospitals (level 1 <5 PPH/year vs. 3 >30 PPH/year). The percentage of PPH requiring red blood cell (RBC) transfusion amounts to <25 % (all levels). A bleeding history (35 %, all levels), laboratory coagulation tests (29 %, all levels) as well as viscoelastic point-of-care coagulation tests (42 %, mainly level 3) are limited in their availability. Blood loss is usually estimated (99 %, all levels), not measured. Tranexamic acid (>80 %, all levels), fibrinogen (>60 %, all levels) and fresh frozen plasma (FFP) (30 %, level 2a) are first line therapeutics. In level 2b and 3 FFP is a second line therapeutic. RBC transfusion is indicated at haemoglobin <5-7 g/dl (57-69 %, all levels), while 15-29 % in level 3 did not base their decision to transfuse RBC on haemoglobin only. CONCLUSIONS: Guideline-consistent haemostatic management of PPH is provided in almost all hospitals independent of the perinatal care level. Deviances from guidelines (measuring blood loss, bleeding history of the patient) affect all levels of perinatal care in Germany.

[Tranexamic acid in the German emergency medical service : A national survey]. / Vorhaltung von Tranexamsäure im deutschen Rettungsdienst : Eine nationale Umfrage.

BACKGROUND: Trauma-induced coagulopathy, one of the leading causes of trauma-related death, is detected in about one of four trauma patients upon hospital admission. The current European Management of Major Bleeding and Coagulopathy Following Trauma guidelines, published in 2013, recommend that tranexamic acid (TXA) be administered as early as possible to inhibit hyperfibrinolysis (grade of recommendation (GoR 1A)). Furthermore, it is suggested that protocols for the management of patients with bleeding or showing signs of bleeding include the administration of the first dose of TXA at the site of injury or during transportation to hospital (GoR 2C). There is no current data showing to what extent TXA is used in the pre-hospital settings in Germany. OBJECTIVES: This study aimed to collect data about the availability of TXA in the German emergency medical service (EMS). We tried to determine how many EMS stored and used TXA, under which circumstances the substance was used and whether any standard operating procedures (SOPs) were in use. The study also tried to determine what dosage recommendations exist. MATERIALS AND METHODS: Between 1 July and 31 August 2015, a total of 326 German emergency medical directors (EMDs) were asked to take part in a survey, which involved answering an online questionnaire. RESULTS: Altogether 163 EMD answered the questionnaire (response rate 50%). The results showed that 52.8% of EMDs stored TXA in their vehicles and 26% planned to do so in the future. The availability of TXA in the EMS has increased since 2010. Most EMDs stated that guidelines were the reason for this. SOPs existed in 17.4%. Dosage recommendations were defined by the EMDs in 76.7%. More than 80% of dosage recommendations followed the European guideline. CONCLUSION: The survey shows a widespread distribution of TXA in the German EMS, which has significantly increased between 2010 and 2015. However, nationwide distribution has not yet been established. This rise in distribution is interpreted as a reaction to national and European guidelines for the management of severe bleeding and trauma care. A remaining question is to determine which patients should be treated with TXA, as hyperfibrinolysis is not detectable at the site of injury.

[Bleeding in patients receiving dual antiplatelet therapy after acute coronary syndrome - significance, prevention and interdisciplinary management]. / Interdisziplinäres Management von Blutungen unter dualer antithrombozytärer Therapie nach akutem Koronarsyndrom.

For secondary prevention of acute coronary syndrome, guidelines recommend dual antiplatelet therapy with acetylsalicylic acid and a P2Y12 receptor antagonist such as clopidogrel, prasugrel or ticagrelor for a period of 12 months. Premature discontinuation of dual antiplatelet therapy is associated with an increased risk of ischaemic events. However, antiplatelet therapy is also associated with an increased risk of bleeding that should not be under- or overestimated. To ensure an optimal care of patients receiving dual antiplatelet therapy after an acute coronary syndrome, an interdisciplinary group of experienced experts in the fields of cardiology, cardiac surgery, gastroenterology, anaesthesiology, intensive care and haemostaseology gathered bleeding-related information and developed recommendations relevant to daily clinical practice. These include the significance of bleeding events in the course of treatment, measures for bleeding prevention and the adequate care of patients with bleedings.

High-dose fibrinogen versus a clinically recommended dose of fresh frozen plasma for reversal of dilutional coagulopathy in an in vitro model of severe hemodilution.

BACKGROUND: Volume substitution using colloids and crystalloids dose-dependently induces dilutional coagulopathy. For treatment, fibrinogen concentrate and fresh frozen plasma are options, though the effective dosage of either agent is unclear. The objective of this study was to evaluate, whether high-dose fibrinogen or recommended doses of fresh frozen plasma are equally effective in reversing profound dilutional coagulopathy in vitro. METHODS: Blood samples of ten healthy volunteers were diluted by 60% with normal saline, balanced 4% gelatin, or balanced 6% hydroxyethyl starch 130/0.42, and supplemented with either 85mg/kg fibrinogen concentrate or 20mL/kg fresh frozen plasma. Conventional coagulation assays (prothrombin time, activated partial thromboplastin time, plasma fibrinogen, factors V and VIII), and activated rotational thromboelastometry (EXTEM: clotting time, clot formation time, FIBTEM: maximum clot firmness) were performed in all samples. RESULTS: For saline and gelatin dilutions, plasma fibrinogen and thromboelastometry parameters normalized by fibrinogen concentrate, while conventional coagulation assays and factors V and VIII remained unaffectedly impaired. Fresh frozen plasma improved both conventional coagulation assays, coagulation factors, and thromboelastometry parameters in saline and gelatin dilutions. For hydroxyethyl starch dilutions, plasma fibrinogen increased by fresh frozen plasma, and even normalized by fibrinogen concentrate. Conventional coagulation assays and factors V and VIII improved by fresh frozen plasma only. Thromboelastometry parameters remained mainly unaffected impaired by both fibrinogen concentrate and fresh frozen plasma. CONCLUSION: High-dose fibrinogen concentrate and clinically recommended doses of fresh frozen plasma are equally effective and can partially restore viscoelastic coagulation assays in profound saline and gelatin dilutions, but only fresh frozen plasma improves conventional coagulation assays. Hydroxyethyl starch-induced disturbance of fibrin polymerization is neither restored by fibrinogen concentrate nor fresh frozen plasma.

[Radiation therapy in patients with cardiac pacemakers or implantable cardioverter defibrillators. Interdisciplinary safety recommendations]. / Strahlentherapie bei Patienten mit Herzschrittmachern oder implantierbaren Kardioverter-Defibrillatoren. Interdisziplinäre Sicherheitsempfehlungen.

BACKGROUND: With increasing numbers of implanted pacemakers and implantable cardioverter defibrillators (ICD) and a rising incidence of malignant tumors, there is a growing probability of radiation-mediated device dysfunction. The only guidelines for the management of patients with cardiac pacemakers in the case of radiation therapy were published in 1994 and have not been updated since then. Based on the current evidence and modern device technology, the present paper aims to develop contemporary and interdisciplinary safety recommendations for the minimization of patient risk. METHODS AND RESULTS: A systematic literature research was carried out including the most relevant medical electronic databases. The search yielded 147 articles published between 1994 and 2012 of which 45 met the selection criteria and of these studies 34 presented primary data (9 in vitro and 25 in vivo studies). The impact of ionizing radiation varied significantly between implanted devices and ranged from no functional changes to complete loss of function. Important device dysfunctions included changes in sensing capability, altered pacing pulses or rate, changed or disabled tachyarrhythmia ICD therapies, early battery depletion and loss of telemetry. Modern pacemakers and ICDs are more sensitive to radiation than older models. Potentially life-threatening complications were observed after exposure of the pulse generator to comparatively low radiation doses (0.11 Gy). CONCLUSIONS: Practical recommendations for patient management and safety are presented that can be readily adopted by any institution carrying out radiation therapy.

[Risk of bleeding and haemorrhagic complication with rivaroxaban--periprocedural management of haemostasis]. / Blutungsrisiko und Blutungsnotfälle unter Rivaroxaban. Periinterventionelles Hämostasemanagement.

UNLABELLED: Rivaroxaban, the first direct factor-Xa inhibitor anticoagulant, has been approved for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery, for stroke prophylaxis in patients with non-valvular atrial fibrillation and for the treatment of deep vein thrombosis. There is no requirement for coagulation monitoring with rivaroxaban in routine clinical practice. However, in certain clinical circumstances such as life-threatening bleeding or an emergency operation the measurement of the thromboplastin time with a sensitive reagent will deliver first information. A quantitative determination of rivaroxaban plasma concentration is possible using an anti-factor Xa assay. In the case of a patient under long-term anticoagulation with rivaroxaban requiring an elective surgery, a discontinuation of rivaroxaban 20 to 30 hours before the operation is sufficient to normalize the associated bleeding risk, as long as the renal and liver function is normal. A longer interval should be taken into consideration, when the patient presents a renal and liver impairment or is of a higher age. In the event of an emergency operation effective rivaroxaban concentrations might be present. Nevertheless, we advise against using a prophylactic dose of factor concentrates. RECOMMENDATIONS: From a clinical perspective, in the event of a minor bleeding we recommend a temporary discontinuation of rivaroxaban, whereas for clinically relevant major or severe bleeding events a mechanical compression or a limited surgical i.e. interventional treatment is required. Supportive measures such as the administration of blood products or tranexamic acid might be beneficial. In addition to haemodynamic supportive measures life threatening bleeding events demand a comprehensive haemostasis management, as well as the application of PCC.