The sensitivity and specificity of rotational thromboelastometry (ROTEM) to detect coagulopathy during moderate and severe postpartum haemorrhage: a prospective observational study

IntroductionPoint-of-care viscoelastic haemostatic assays such as rotational thromboelastometry (including ROTEM and TEG) have been used in the management of postpartum haemorrhage (PPH). This study compared results obtained from the automated ROTEM Sigma with laboratory tests of coagulation and platelet count during PPH.MethodsA prospective observational cohort study recruited women with PPH ≥1000 mL (or clinical concern of bleeding). The Fibtem A5, Extem CT and Pltem (Extem A5 – Fibtem A5) results were compared with laboratory tests of fibrinogen, prothrombin time (PT), activated partial thromboplastin time (APTT) and platelet count.Results521 women were recruited, including 274/277 (98.9%) of women with PPH ≥1500 mL. Fibtem A5 results were matched with laboratory fibrinogen in 552/644 (85.7%) samples. The incidence of abnormal laboratory results was low: fibrinogen ≤2 g/L 23/464 (5.0%), PT or APTT >1.5 × midpoint of reference range 4/464 (0.9%), and platelet count <75 × 10⁹/L 11/477 (2.3%). Area-under-the-receiver operator characteristic curve for Fibtem A5 to detect fibrinogen ≤2 g/L was 0.96 (95% Confidence Interval (CI) 0.94 to 0.98, P<0.001), with sensitivity and specificity of Fibtem A5 ≤11 mm to detect fibrinogen ≤2 g/L of 0.76 and 0.96. Prolonged Extem CT results improved after treatment of hypofibrinogenaemia alone. Intervention points for platelet and fresh frozen plasma (FFP) transfusion based on ROTEM Sigma parameters could not be established.ConclusionDuring PPH (≥1000 mL or cases of clinical concern about bleeding), ROTEM Sigma Fibtem A5 can detect fibrinogen ≤2 g/L and guide targeted fibrinogen replacement. Laboratory results should continue to be used to guide platelet and FFP transfusion.     

Comparison of haematological indices and transfusion management in severe and massive postpartum haemorrhage: analysis of a two-year national prospective observational study

IntroductionThis two-year prospective cohort study compared the management of women experiencing severe or massive postpartum haemorrhage (PPH) to explore the impact of targeted blood product administration on reducing PPH progression (from >1500 mL to ≥2500 mL blood loss). During the study, viscoelastic haemostatic assays (VHA) guided blood product transfusion.MethodsAll women experiencing blood loss after PPH >1000 mL were included in a national database. Haematological indices, transfusion and PPH aetiology were analysed in severe (>1500 mL blood loss or transfusion of any blood product) and massive PPH (≥2500 mL blood loss or transfusion ≥5 units red blood cells).ResultsOf the 61 094 maternities in Wales (2017 to 2018), 2111 had severe and 349 massive PPH. Red blood cells were transfused to 42.5% severe and 80.6% massive PPH cases. Hypofibrinogenaemia (fibrinogen <2 g/L and/or Fibtem A5 <12 mm) was the most frequent coagulation abnormality, occurring in 5.4% severe and 17.0% massive PPH, with blood coagulation products (fresh frozen plasma, platelets, cryoprecipitate and/or fibrinogen concentrate) administered to 3.6% and 22.9%. Women with hypofibrinogenaemia received targeted fibrinogen replacement in 97.8% severe and 93.6% massive PPH. The only aetiology with similar rates of hypofibrinogenaemia in severe and massive PPH was abruption (40.0% and 36.8%).ConclusionHypofibrinogenaemia was less frequent in severe PPH, although coagulopathy was observed across a range of PPH aetiologies, highlighting the importance of coagulation testing for all. Cases of abruption in severe and massive PPH had similar rates of hypofibrinogenaemia. Early VHA-guided fibrinogen replacement may reduce PPH progression in abruption and requires further evaluation.     

The incidence,aetiology, and coagulation management of massive postpartum haemorrhage: a two-year national prospective cohort study

IntroductionBetween 2017 and 2018 a national quality improvement initiative was introduced incorporating point-of-care viscoelastic haemostatic assays (VHA) to guide blood product transfusion. Laboratory coagulation profiles, use and results of VHA, and administration of blood products were investigated.MethodsA two-year prospective cohort study of maternal outcomes of women experiencing massive postpartum haemorrhage (PPH) >1000 mL in Wales. In this study, cases of massive PPH (≥2500 mL and/or ≥5 units red blood cell (RBC) transfusion) were identified.ResultsMassive PPH occurred in 349 of 60 914 maternities (rate 5.7 per 1000). There were no deaths from PPH. Intensive care unit admission and/or hysterectomy occurred in 34/311 (10.9%) and 16/347 (4.6%), respectively. The leading cause of massive PPH was genital tract trauma (107/349, 30.6%). Two hundred and seventy-nine (80.6%) required RBC transfusion and 79/345 (22.9%) received at least one blood coagulation product. Results of VHA were recorded in 245/349 (70.2%), with 44/98 (44.9%) women tested in the first six months vs 63/77 (81.8%) in the final six months. Hypofibrinogenaemia (Clauss fibrinogen <2 g/L or FIBTEM A5 <12 mm) was observed in 56/328 (17.1%) of women, thrombocytopaenia (count <75 × 10⁹/L) in 17/334 (5.1%) and either PT or aPTT >1.5×reference range in 10/293 (3.4%).ConclusionIn Wales, the use of VHA in cases of massive PPH increased over time, enabling clinicians to adopt a targeted, patient-specific approach to blood product administration, with only 22.9% of women receiving blood coagulation products and 17.1% having a documented clotting abnormality.     

Factor XIII activity at onset of labour and association with postpartum haemorrhage: an exploratory post-hoc study

BackgroundPlatelets, fibrinogen and factor XIII (FXIII) are required to form a stable clot in case of haemorrhage. The aims of this study were to evaluate a possible association between FXIII activity at the onset of labour and postpartum haemorrhage (PPH), and to ascertain whether FXIII activity at labour onset differs from after delivery.MethodsFXIII activity in 239 women with PPH (blood loss >1 L) and in 76 women without PPH was compared, as was activity before and after delivery in a third group of 80 women.ResultsFXIII activity at onset of labour was significantly lower in the PPH group compared with the control group (mean ± SD 0.98 ± 0.20 vs 1.05 ± 0.17 kIU/L; P=0.0006). The difference was significantly greater in subgroups having vaginal delivery with no oxytocin stimulation or uterine exploration (absolute difference 0.131; 95% CI 0.055 to 0.206), compared with a subgroup experiencing any complication (0.04; 95% CI −0.023 to 0.104; interaction P-value 0.098). There was a weak but statistically significant inverse correlation between FXIII and estimated blood loss (r=−0.25; P=0.030) in the control group but not the PPH group. There was no significant difference between FXIII activity at onset of labour and after delivery (mean ± SD 1.03 ± 0.17 vs 1.04 ± 0.19 kIU/L; P=0.093).ConclusionsAt the onset of labour women with a subsequent PPH had significantly lower mean FXIII activity than that of women without PPH. This difference was small and within normal limits. FXIII activity did not change during normal delivery. The importance of FXIII during PPH requires study.     

The association of shock index and haemoglobin variation with postpartum haemorrhage after vaginal delivery: a prospective cohort pilot study

IntroductionShock index and continuous non-invasive haemoglobin monitoring (SpHb) have both been proposed for the timely recognition of postpartum haemorrhage (PPH). We sought to determine, in parallel, the association of each of shock index and SpHb with blood loss after vaginal delivery.MethodsSixty-six women were recruited to this prospective observational study. Shock index and SpHb were recorded postpartum for 120 min. The association between each of shock index and SpHb with quantitative blood loss (QBL) at 30, 60 and 120 min postpartum was determined using linear mixed models. Area-under-the-receiver-operator-characteristic (AUROC) curves were constructed to evaluate the diagnostic ability of shock index and SpHb to detect PPH (defined as QBL ≥1000 mL).ResultsShock index trend was associated with QBL over the first 30 min (r=0.37, P=0.002), but not over 60 or 120 min. There was an association of SpHb trend with QBL over the first 30 min (P=0.06), but not over 60 min (r=−0.32, P=0.009) or 120 min (r=−0.26, P=0.03). Maximum shock index within 60 min correlated with QBL (r=0.54, P <0.001) and was a predictor of PPH (P=0.0012, AUROC 0.796). Maximum change in SpHb within 60 min negatively correlated with QBL (r=−0.4, P <0.001) and was a predictor of PPH (P=0.048, AUROC 0.761).ConclusionsThe trend of shock index and its peak values are associated with blood loss after vaginal delivery and are early indicators of PPH. Negative trend of SpHb is a late sign of PPH and has a weaker association with blood loss than shock index.     

Management of postpartum haemorrhage: from research into practice,a narrative review of the literature and the Cardiff experience

Postpartum haemorrhage (PPH) is caused by obstetric complications but may be exacerbated by haemostatic impairment. In a 10-year programme of research we have established that haemostatic impairment is uncommon in moderate PPH and that fibrinogen falls earlier than other coagulation factors. Laboratory Clauss fibrinogen and the point-of-care surrogate measure of fibrinogen (FIBTEM A5 measured on the ROTEM® machine) are predictive biomarkers for progression from early to severe PPH, the need for blood transfusion and invasive procedures to control haemorrhage. Fibrinogen replacement is not required in PPH unless the plasma level falls below 2 g/L or the FIBTEM A5 is below 12 mm. Deficiencies of coagulation factors other than fibrinogen are uncommon even during severe PPH, and ROTEM® monitoring can inform withholding FFP safely in most women. In the absence of placental abruption, clinically significant thrombocytopenia is uncommon unless the platelet count is low before the bleed started, or very large bleeds (>5000 mL) occur. Measuring blood loss is feasible in routine practice during PPH and is more accurate than estimation. These research findings have been collated to design an ongoing quality improvement programme for all maternity units in Wales called OBS Cymru (Wales) (The Obstetric Bleeding Strategy for Wales).     

Anaesthetic management of liver haemorrhage during laparotomy in a premature infant with necrotizing enterocolitis

The case of a 680 g premature baby who developed massive spontaneous liver haemorrhage during laparotomy for necrotizing enterocolitis is reported. The infant survived due to rapid and massive fluid administration, including transfusion of large volumes of blood and blood products, in combination with high dose inotropic support and the surgical use of packing with thrombostatic sponges. Good venous access, including two central venous lines, turned out to be very useful.     

Major complications of airway management: a prospective multicentre observational study

We conducted an observational study of serious airway complications, using similar methods to the fourth UK National Audit Project (NAP4) over a period of 1 year across four hospitals in one region in the UK. We also conducted an activity survey over a week, using NAP4 methods to yield an estimate for relevant denominators to help interpret the primary data. There were 17 serious airway complications, defined as: failed airway management leading to cancellation of surgery (eight); airway management in recovery (five); unplanned intensive care admission (three); and unplanned emergency front of neck access (one). There were no reports of death or brain damage. This was an estimate of 0.028% (1 in 3600) complications using the denominator of 61,000 general anaesthetics per year in the region. Complications in patients with ‘predicted easy’ airways were rare (approximately 1 in 14,200), but 45 times more common in those with ‘predicted difficult’ airways (approximately 1 in 315). Airway management in both groups was similar (induction of anaesthesia followed by supraglottic airway or tracheal tube). Use of awake/sedation intubation, videolaryngoscopy and high-flow nasal oxygenation were uncommon even in the predicted difficult airway patients (in 2.7%, 32.4% and 9.5% of patients, respectively). We conclude that the incidence of serious airway complications is at least as high as it was during NAP4. Despite airway prediction being used, this is not informing subsequent management.     

Reliability of the 'pop' sign as an indicator of dural puncture during obstetric spinal anaesthesia: a prospective observational clinical study

Anaesthetists rely upon a loss of resistance and flow of cerebrospinal fluid to indicate when a spinal needle has breached the dura. The loss of resistance is not always felt, with the danger that the needle may be advanced into neurological tissue. One hundred women undergoing elective caesarean section were recruited and spinal anaesthesia, using a 27-G Whitacre needle, was performed using an incremental advancement technique. After each advancement of the needle, and before removing the stylet, it was recorded whether the anaesthetist had perceived any sign that the dura had been breached, and then whether cerebrospinal fluid had been obtained. Six patients were not included in the study due to technical difficulties. In 27 of 94 patients (29%) there was no clear tactile sign that the dura had been breached when cerebrospinal fluid was obtained. This study demonstrates that loss of resistance is not always felt when a 27-G spinal needle breaches the dura in the pregnant woman.     

Incidence,severity, and determinants of uterine contraction pain after vaginal delivery: a prospective observational study

BackgroundPostpartum uterine contraction pain has not been studied sufficiently. We aimed to assess the incidence, intensity, and risk factors for postpartum uterine contraction pain.MethodsWomen with singleton pregnancies who delivered vaginally were enrolled in this prospective, observational, single-institution study. We determined the numerical rating scale (NRS) score (0 to 10-point) for uterine contraction pain at 6, 12, 24, and 48 h after delivery. Generalized mixed modeling was used to identify the risk factors for significant postpartum uterine contraction pain (NRS score ≥3). We compared the incidence and severity of postpartum uterine contraction pain between nulliparous and multiparous women.ResultsTwo hundred and sixty-five nulliparous and 139 multiparous women were included. Forty-seven percent (188/404; 95% confidence interval [CI] 41.7% to 51.4%) of women presented with significant uterine contraction pain within 48 h of delivery. The generalized mixed model showed that nulliparous women had a lower risk of significant postpartum uterine contraction pain compared with multiparous women (odds ratio [OR] 0.33, 95% CI 0.17 to 0.61; P<0.001). Women with a history of dysmenorrhea had higher risk of significant postpartum uterine contraction pain (OR 1.77, 95% CI 1.12 to 2.79; P=0.014). Both nulliparous and multiparous women reported more intense uterine contraction pain while breastfeeding (P<0.001).ConclusionsPostpartum uterine contraction pain is common and severe in some women. Parity and history of dysmenorrhea are significant risk factors for significant postpartum uterine contraction pain.     

血液透析上机阶段护理中断事件现况调查分析

目的 调查血液透析上机阶段护理中断事件发生现况,为针对性干预提供参考。方法 观察血液透析护士在上机过程中发生的护理中断事件,包括次数、持续时间、来源及结局等。结果 共观察34名血液透析护士1 630例次上机操作,发生护理中断2 611次,平均每个上机过程发生中断1.6次。中断事件主要来源于护士同事（46.3%）、患者或家属（42.0%）;中断原因前3位为协助双人查对（45.5%）、与治疗相关的交谈（22.0%）、与治疗无关的交谈（16.4%）;护士采取的应对方式为立即应对（57.2%）、多任务（20.2%）、延迟执行（18.6%）、拒绝执行（4.0%）;中断事件导致消极型结局2 354次（90.2%）,其中43次上机错误/隐患事件（1.6%）。结论 血液透析上机阶段护理中断事件发生频率高,来源多,原因复杂,且多为消极型结局,可诱发护理不良事件。应加强对护士透析工作的支持,同时加强中断事件认知培训,保障患者安全。     

From intracranial pressure to intracranial pressure wave-guided intensive care management of a patient with an aneurysmal subarachnoid haemorrhage

We report on a 65-year-old female with an aneurysmal subarachnoid hemorrhage (SAH) that was followed clinically, radiologically and electrophysiologically before and after converting from intracranial pressure (ICP)-guided to ICP wave-guided intensive care management. Intracranial pressure-guided management is aimed at keeping mean ICP < 15-20 mmHg, while ICP wave-guided management is aimed at keeping mean ICP wave amplitude < 5 mmHg. The aims of management were obtained by adjusting cerebrospinal fluid (CSF) draining volume from her external ventricular drain. No improvement was seen clinically or in cerebral magnetic resonance imaging (MRI) scans during the ICP-guided management. Clinical, MRI and neurophysiologic (electroencephalography and auditory evoked responses) improvements were obvious within 2 days after converting from ICP- to ICP wave-guided management. This case report describes how we used various ICP parameters to guide intensive care management of an aneurysmal SAH patient.     

Temporomandibular joint dysfunction following the use of a supraglottic airway device during general anaesthesia: a prospective observational study

Supraglottic airway devices are commonly used to manage the airway during general anaesthesia. There are sporadic case reports of temporomandibular joint dysfunction and dislocation following supraglottic airway device use. We conducted a prospective observational study of adult patients undergoing elective surgery where a supraglottic airway device was used as the primary airway device. Pre-operatively, all participants were asked to complete a questionnaire involving 12 points adapted from the Temporomandibular Joint Scale and the Liverpool Oral Rehabilitation Questionnaire. Objective measurements included inter-incisor distance as well as forward and lateral jaw movements. The primary outcome was the inter-incisor distance, an accepted measure of temporomandibular joint mobility. Both the questionnaire and measurements were repeated in the postoperative period and we analysed data from 130 participants. Mean (SD) inter-incisor distance in the pre- and postoperative period was 46.5 (7.2) mm and 46.3 (7.5) mm, respectively (p = 0.521) with a difference (95%CI) of 0.2 (−0.5 to 0.9) mm. Mean (SD) forward jaw movement in the pre- and postoperative period was 3.6 (2.4) mm and 3.9 (2.4) mm, respectively (p = 0.018). Mean (SD) lateral jaw movement to the right in the pre- and postoperative period was 8.9 (4.1) mm and 9.1 (4.0) mm, respectively (p = 0.314). Mean (SD) lateral jaw movement to the left in the pre- and postoperative period was 8.8 (4.0) mm and 9.3 (3.6) mm, respectively (p = 0.008). The number of patients who reported jaw clicks or pops before opening their mouth as wide as possible was 28 (21.5%) vs. 12 (9.2%) in the pre- and postoperative period, respectively (p < 0.001) with a difference (95%CI) of 12.3% (6.7–17.9%). There was no significant difference in the responses to the other 11 questions or in the number of patients who reported pain in the temporomandibular joint area postoperatively. No clinically significant dysfunction of the temporomandibular joint following the use of supraglottic airway devices in the postoperative period was identified by either patient questionnaires or objective measurements.     

Validation of an obstetric quality of recovery scoring tool (ObsQoR-11) after elective caesarean delivery in a developing country: a prospective observational study

BackgroundThe obstetric quality of recovery scoring tool (ObsQoR-11) was developed and validated in the United Kingdom for use after elective and emergency caesarean delivery. Quality of recovery scoring tools validated in one country may not be valid in other countries with significant cultural, socio-economic and linguistic variations. The aim of the current study was to validate a Hindi version of the ObsQoR-11.MethodsIn this prospective observational study, 100 parturients who underwent elective caesarean delivery in a tertiary care obstetric referral university hospital in North India were asked to complete a Hindi version of the ObsQoR-11 scoring tool 24 h after surgery. The performance of the Hindi version of ObsQoR-11 was assessed using measures of validity, reliability, and feasibility.ResultsThe Hindi version of ObsQoR-11 correlated moderately with the global health visual analogue scale (r=0.45, 95% CI 0.27 to 0.59; P <0.0001) and discriminated well between good and poor recovery (mean (SD) score 84.6 (9.4) vs 75.0 (11.2); P <0.0001). The reliability and internal consistency were moderate (Cronbach’s alpha=0.66; Spearman-Brown Prophesy Reliability estimate=0.57) with good repeatability (intraclass correlation coefficient 0.85, 95% CI 0.69 to 0.93; P <0.0001) and no floor or ceiling effects. All parturients completed the questionnaire in a (median (IQR) time of completion of 3 (1.5 – 5.5) min).ConclusionThe Hindi version of the ObsQoR-11 questionnaire is a promising scoring tool to evaluate quality of recovery after elective caesarean delivery. Further research is needed to evaluate the Hindi tool in other institutions in India as well as in other languages.     

Long-term results of frey’s procedure for chronic pancreatitis: a longitudinal prospective study on 40 patients

Only limited prospective data are available regarding the long-term outcome of local resection of the pancreatic head in combination with longitudinal pancreaticojejunostomy in patients with chronic pancreatitis. From 1997 to 2001, 40 patients affected by chronic pancreatitis were subjected to the Frey’s procedure. Preoperative selection criteria included confirmed diagnosis of chronic pancreatitis, dilation of Wirsung’s duct to a diameter greater than 6 mm, and the absence of obstructive chronic pancreatitis secondary to fibrotic stenosis at the pancreatic body or tail. Preoperative pain was present in 38 cases (95%), and follow-up was performed in all patients at least once yearly up to 2003 (median 60 months, inter percentile range 20.1-79.6). Postoperative morbidity occurred in three cases (7.5%). The percentage of pain-free patients was 94.7%, 93.7%, 87.5%, and 90% at 1, 2, 3, and 4/5 years after surgical operation, respectively. After surgery, three patients developed diabetes. Both the body mass index and quality of life showed statistically significant improvements at all follow-up intervals. Whenever surgery is indicated, the short-term and long-term outcomes confirm that Frey’s procedure is an appropriate means of management for patients with chronic pancreatitis in the absence of doubts of neoplasia and/or distal ductal obstruction.     

Factors associated with time to defecate and outcomes in critically ill patients: a prospective,multicentre, observational study

Delayed defecation is common in patients on intensive care. We aimed to determine factors associated with time to defecation after admission to intensive care and in turn its association with length of stay and mortality. We studied 396 adults admitted to one of five intensive care units in whom at least 2 days’ invasive ventilation was anticipated during an expected stay of at least 3 days. The median (IQR [range]) time to defecate by the 336 out of 396 (84%) patients who did so before intensive care discharge was 6 (4-8 [1–18]) days. Defecation was independently associated with five factors, hazard ratio (95%CI), higher values indicating more rapid defecation: alcoholism, 1.32 (1.05–1.66), p = 0.02; laxatives before admission, 2.35 (1.79–3.07), p < 0.001; non-invasive ventilation, 0.54 (0.36–0.82), p = 0.004; duration of ventilation, 0.78 (0.74–0.82), p < 0.001; laxatives after admission, 1.67 (1.23–2.26), p < 0.001; and enteral nutrition within 48 h of admission, 1.43 (1.07–1.90), p = 0.01. Delayed defecation was associated with prolonged intensive care stay but not mortality.