Clinical value of early assessment of hyperfibrinolysis by rotational thromboelastometry during postpartum hemorrhage for the prediction of severity of bleeding: a multicenter prospective cohort study in the Netherlands

Introduction: Coagulopathy may be the result of hyperfibrinolysis and could exacerbate bleeding following childbirth. Timely recognition of hyperfibrinolysis during the earliest stages of postpartum hemorrhage could identify women at risk of more severe blood loss who may benefit from targeted anti-fibrinolytic therapy. Rotational thromboelastometry (ROTEM (R)) is a point-of-care test that could detect hyperfibrinolysis. The aim of this study was to evaluate whether early assessment of hyperfibrinolysis by ROTEM during postpartum hemorrhage could predict progression to severe postpartum hemorrhage.Material and methods: During a prospective cohort study in the Netherlands among women with postpartum hemorrhage (total blood loss at least 1000 ml within 24 h after childbirth) ROTEM measurements were performed following 800-1500 ml of blood loss. Hyperfibrinolysis was defined as an enzymatic fibrinolysis index (ROTEM EXTEM maximum clot lysis [ML] minus the ROTEM APTEM ML) above 15%. Severe postpartum hemorrhage was defined as a composite end point of total blood loss greater than 2000 ml, transfusion of four or more units of packed cells, and/or need for an invasive intervention. The predictive value of hyperfibrinolysis for progression to severe postpartum hemorrhage was assessed by area under the receiver operating curve ( AUC) and positive and negative predictive values.Trial registration: ClinicalTrials. gov (NCT02149472).Results: Of 390 women included, 82 (21%) had severe postpartum hemorrhage. Four (1%) women had thromboelastometric evidence of hyperfibrinolysis, of whom two developed severe postpartum hemorrhage. The AUC for enzymatic fibrinolysis index more than 15% for progression to severe postpartum hemorrhage was 0.47 (95% CI 0.40-0.54). Positive and negative predictive values for this index were 50.0% (95% CI 6.8-93.2) and 79.3% (95% CI 74.9-83.2), respectively.Conclusions: Thromboelastometric evidence of hyperfibrinolysis was rare in women with postpartum hemorrhage when assessed between 800 and 1500 ml of blood loss. The clinical predictive value of viscoelastometric point-of-care testing for hyperfibrinolysis for progression to severe postpartum hemorrhage during early postpartum hemorrhage is limited.Clinical epidemiolog

Coagulation parameters during the course of severe postpartum hemorrhage: a nationwide retrospective cohort study

Research into fetal development and medicin

Clinical value of early viscoelastometric point-of-care testing during postpartum hemorrhage for the prediction of severity of bleeding: a multicenter prospective cohort study in the Netherlands

Introduction To evaluate rotational fibrin-based thromboelastometry (ROTEM(R) FIBTEM) with amplitude of clot firmness at 5 min (A5) as an early point-of-care parameter for predicting progression to severe postpartum hemorrhage, and compare its predictive value with that of fibrinogen.Material and methods Prospective cohort study in the Netherlands including women with 800-1500 ml of blood loss within 24 h following birth. Blood loss was quantitatively measured by weighing blood-soaked items and using a fluid collector bag in the operating room. Both FIBTEM A5 values and fibrinogen concentrations (Clauss method) were measured between 800 and 1500 ml of blood loss. Predictive accuracy of both biomarkers for the progression to severe postpartum hemorrhage was measured by area under the receiver operating curves (AUC). Severe postpartum hemorrhage was defined as a composite endpoint of (1) total blood loss >2000 ml, (2) transfusion of >= 4 packed cells, and/or (3) need for an invasive intervention to cease bleeding.Results Of the 391 women included, 72 (18%) developed severe postpartum hemorrhage. Median (IQR) volume of blood loss at blood sampling was 1100 ml (1000-1300) with a median (interquartile range [IQR]) fibrinogen concentration of 3.9 g/L (3.4-4.6) and FIBTEM A5 value of 17 mm (13-20). The AUC for progression to severe postpartum hemorrhage was 0.53 (95% confidence interval [CI] 0.46-0.61) for FIBTEM A5 and 0.58 (95% CI 0.50-0.65) for fibrinogen. Positive predictive values for progression to severe postpartum hemorrhage for FIBTEM A5 <= 12 mm was 22.5% (95% CI 14-33) and 50% (95% CI 25-75) for fibrinogen <= 2 g/L.Conclusions The predictive value of FIBTEM A5 compared to fibrinogen concentrations measured between 800 and 1500 ml of blood loss following childbirth was poor to discriminate between women with and without progression towards severe postpartum hemorrhage.Research into fetal development and medicin

Exploring the applicability of the pregnancy and childbirth outcome set: A mixed methods study

Objective: The International Consortium for Health Outcomes Measurement developed the Pregnancy and Childbirth (PCB) outcome set to improve value-based perinatal care. This set contains clinician-reported outcomes and patient-reported outcomes. We validated the set for use in the Netherlands by exploring its applicability among all end-users prior to implementation. Methods: A mixed-methods design was applied. A survey was performed to assess patients (n = 142), professionals (n = 134) and administrators (n = 35) views on the PCB set. To further explore applicability, separate focus groups were held with representatives of each of these groups. Results: The majority of survey participants agreed that the PCB set contains the most important outcomes. Patient-reported experience measures were considered relevant by the majority of participants. Perceived relevance of patient-reported outcome measures varied. Main themes from the focus groups were content of the set, data collection timing, implementation (also IT and transparency), and quality-based governance. Conclusion: This study supports suitability of the PCB outcome set for implementation, evaluation of quality of care and shared decision making in perinatal care. Practice Implications: Implementation of the PCB set may change existing care pathways of perinatal care. Focus on transparency of outcomes is required in order to achieve quality-based governance with proper IT solutions

Recognition and management of persistent postpartum haemorrhage: Time to take timing seriously

Persistent postpartum haemorrhage is a major cause of maternal mortality and severe morbidity after childbirth. Part I of this thesis discusses uncertainties in management of women with postpartum haemorrhage and opportunities to improve maternal outcome. Part II is a description of women with the highest risk of adverse haemorrhage-related outcomes: women with concurrent preeclampsia and women in whom the bleeding is refractory to first-line interventions to stop the haemorrhage. Part III of the thesis compares the outcomes after different strategies for fluid resuscitation and after different strategies for timing of plasma transfusion in these women. In part III we also discuss methodological challenges encountered in studies among women with severe postpartum haemorrhage, methods to deal with this time-dependent confounding.   </p

Management of postpartum hemorrhage: how to improve maternal outcomes?

Clinical epidemiolog

The Asbestos Sheet Jan. 1965

BackgroundPostpartum hemorrhage remains the leading cause of maternal morbidity and mortality worldwide. Few population-based studies have examined the epidemiology of massive transfusion for postpartum hemorrhage. The aim of this study was to determine the incidence, management, and outcomes of women with postpartum hemorrhage who required massive transfusion in the Netherlands between 2004 and 2006.MethodsData for all women from a gestational age of 20 weeks onwards who had postpartum hemorrhage requiring eight or more red blood cell concentrates were obtained from a nationwide population-based cohort study including all 98 hospitals with a maternity unit in the Netherlands.ResultsThree hundred twenty-seven women who had postpartum hemorrhage requiring massive transfusion were identified (massive transfusion rate 91 per 100,000 deliveries (95% confidence interval: 81–101)). The median blood loss was 4500 mL (interquartile range 3250–6000 mL) and the median number of red blood cell concentrates transfused was 11 units (interquartile range 9–16 units). Among women receiving massive transfusion, the most common cause of hemorrhage was uterine atony. Eighty-three women (25%) underwent hysterectomy, 227 (69%) were admitted to an intensive care unit, and three women died (case fatality rate 0,9%).ConclusionThe number of women in the Netherlands who had postpartum hemorrhage treated with massive transfusion was relatively high compared to other comparable settings. Evidence-based uniform management guidelines are necessary.Research into fetal development and medicin

Predictive value of a bleeding score for postpartum hemorrhage

Background: A reliable screening tool that could contribute to the identification of women with an increased risk of postpartum hemorrhage would be of great clinical significance.Objectives: The aim of this study was to examine the added predictive value of a bleeding assessment tool for postpartum hemorrhage exceeding 1000mL.Patients/Methods: Prospective two-center cohort study among 1147 pregnant women visiting the outpatient clinic or the maternity ward who completed a bleeding assessment tool prior to birth. The condensed MCMDM-1VWD bleeding assessment tool was adjusted to a questionnaire that could be used as a self-assessment bleeding tool. A score of 4 was considered to be abnormal.Results: In the 1147 pregnant women in our cohort, bleeding scores ranged from -3 to 13, with a median of 1 (IQR -1 to 3); 197 (17%) women developed postpartum hemorrhage. Among women with a history of postpartum hemorrhage 29% developed postpartum hemorrhage. Among 147 women with an abnormal bleeding score (4), 27 (18%) developed postpartum hemorrhage, whereas the remaining 170 cases of postpartum hemorrhage had a normal bleeding score. Despite the high incidence of postpartum hemorrhage, the ability of the bleeding score to predict postpartum hemorrhage was poor: area under receiver operating curve 0.53 (95% CI 0.49-0.58) for postpartum hemorrhage (PPH) 1000mL.Conclusions: A history of significant postpartum hemorrhage was associated with an increased risk of subsequent postpartum hemorrhage. However, screening with a bleeding assessment tool did not help to discriminate women who will develop postpartum hemorrhage from women who will not.Clinical epidemiolog

Comparison of thromboelastometry by ROTEM (R) Delta and ROTEM (R) Sigma in women with postpartum haemorrhage

Haemostatic treatment in women experiencing postpartum haemorrhage is increasingly based on point-of-care devices such as ROTEM (R) thromboelastometry. Recently, a fully automated successor of the ROTEM (R) Delta device, the ROTEM (R) Sigma was introduced. To determine whether these devices provide similar results, we compared ROTEM (R) parameters using the ROTEM (R) Delta and Sigma devices in women experiencing postpartum haemorrhage. Prospective observational cohort study of 23 women experiencing postpartum haemorrhage. ROTEM (R) INTEM, EXTEM, FIBTEM and APTEM measurements handled by the ROTEM (R) Delta and Sigma devices were compared. ROTEM (R) FIBTEM values were also related to Clauss fibrinogen values. A correlation of Spearman's r (r(s)) varying between 0.76 and 0.95 was displayed between clot firmness measured in millimeters at 5 (A5), 10 (A10) and 20 (A20) minutes after start of clot formation measured by EXTEM, INTEM and APTEM assays executed on both devices; A5, A10 and A20 of FIBTEM correlated less well (r(s) between 0.71 and 0.74), especially after five and ten minutes. Correlation between both devices regarding clotting time (CT) was poor. The observed correlation between levels of Clauss fibrinogen and FIBTEM A5 was r(s) = 0.70, (95% confidence interval (CI): 0.38 to 0.87) for Delta and r(s) = 0.85, (CI 0.65 to 0.94) for Sigma. A5, A10 and A20 measured in EXTEM, INTEM and APTEM obtained from ROTEM (R) Delta and Sigma devices were similar. EXTEM, FIBTEM and APTEM CT values from both devices showed no correlation. Substantial variation was found between FIBTEM assays of the devices. Consequently, results of FIBTEM assays should always be interpreted in the context of device-specific reference values. Correlation with Clauss fibrinogen was better in the ROTEM (R) Sigma device.Clinical epidemiolog

The effect of tranexamic acid on blood loss and maternal outcome in the treatment of persistent postpartum hemorrhage: A nationwide retrospective cohort study

Obstetric