Four years' experience of a ROTEM® -guided algorithm for treatment of coagulopathy in obstetric haemorrhage.

We report four years of observational data from a large UK hospital and tertiary referral unit, following the introduction of a rotational thromboelastometry-guided algorithm for treatment of coagulopathy in major obstetric haemorrhage. Fibrinogen concentrate was used to treat acquired hypofibrinogenaemia as defined by a FibTEM A5 value of < 7 mm, or 7-12 mm with ongoing or high risk of haemorrhage. Of 32,647 deliveries over 4 years, 893 (2.7%) women had an estimated blood loss ≥ 1500 ml. Two-hundred and three (23%) of these had a FibTEM A5 ≤ 12 mm and 110 received fibrinogen concentrate. We compared clinical outcomes and blood product use with 52 patients who met the same criteria, over a 12-month pre-intervention period during which shock packs were used. In the algorithm group, there was a significant reduction in the number of units (p < 0.0001) and total volume (p = 0.0007) of blood products transfused, with a reduction in transfusion-associated circulatory overload (p = 0.002). Women with placental abruption exhibited more severe coagulopathy and required higher doses of fibrinogen concentrate than women who bled due to other causes. Analysis of rotational thromboelastometry results demonstrated that coagulopathy is not observed in all women who suffer obstetric haemorrhage and cannot be predicted solely by blood loss. Therefore, formulaic treatment with blood products is not justified. When coagulopathy does occur, it appears to be multifactorial and can be severe. Point-of-care testing allows early identification and individualised treatment of coagulopathy. This is supported by the improved outcomes reported.

Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study.

OBJECTIVE: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. DESIGN: A two-round Delphi survey and face-to-face meeting. POPULATION: Healthcare professionals and women's representatives. METHODS: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. MAIN OUTCOME MEASURES: Outcomes from systematic reviews and consultations. RESULTS: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. CONCLUSIONS: These COS will help standardise outcome reporting in PPH trials. TWEETABLE ABSTRACT: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.

Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial.

BACKGROUND: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed size. METHODS: Women with PPH 1000-1500 ml were enrolled. If Fibtem A5 was ≤15 mm and bleeding continued, subjects were randomized to fibrinogen concentrate or placebo. The primary outcome compared the number of units of red blood cells, plasma, cryoprecipitate and platelets transfused. RESULTS: Of 663 women enrolled 55 were randomized. The adjusted incidence rate ratio (IRR) (95% CI) for the number of allogeneic units transfused in the fibrinogen group compared with placebo was 0.72 (0.3-1.7), P =0.45. In pre-specified subgroup analyses, subjects who had a Fibtem A5 ≤12 mm at the time of randomization and who received fibrinogen concentrate received a median (25th-75th centile) of 1 (0-4.5) unit of allogeneic blood products and had an additional 300 (100-350) ml blood loss whereas those who received placebo also received 3 (0-6) units of allogeneic blood products and had 700 (200-1550) ml additional blood loss; these differences were not statistically significantly different. There was one thrombotic event in each group. CONCLUSIONS: Infusion of fibrinogen concentrate triggered by Fibtem A5 ≤15 mm did not improve outcomes in PPH. Pre-specified subgroup analyses suggest that fibrinogen replacement is not required if the Fibtem A5 is > 12 mm or Clauss fibrinogen >2 g litre -1 , but an effect below these levels cannot be excluded. The raised fibrinogen at term appears to be a physiological buffer rather than required for haemostasis. TRIAL REGISTRATION: ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 , last accessed 5 July 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11 , last accessed 5 July 2017).

Viscoelastometry guided fresh frozen plasma infusion for postpartum haemorrhage: OBS2, an observational study.

BACKGROUND: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. Based on data from trauma studies, empirical infusions of fresh frozen plasma (FFP) are often given during severe PPH if coagulation tests are unavailable. This study observed a cohort of women with moderate/severe PPH in whom FFP infusion was guided by the use of viscoelastometric point-of-care testing (VE-POCT) and clinical assessment. METHODS: Women were enrolled into this observational study when blood loss was measured or suspected to be about 1000 mL. If Fibtem A5 determined by Rotem ® thromboelastometry remained >15 mm, or bleeding stopped, FFP was withheld. If Fibtem A5 was ≤15 mm and bleeding ongoing, women were randomized into an interventional study as previously reported. Clinical and laboratory outcomes were recorded. RESULTS: The study recruited 605 women and 98% had FFP withheld. The median (25 th -75 th centile) total blood loss was 1500 (1300-2000) mL with 300 (50-545) mL occurring after enrolment. Total blood loss was >2500 mL in 40/605 (6.6%) women. RBCs were transfused in 141/605 (23.3%) patients and 11 (1.8%) received ≥4 units. At least one invasive procedure was performed in 283/605 (46.8%) women. Level 3 care was required for 10/605 (1.7%) women. No women developed clinically significant haemostatic impairment. CONCLUSIONS: Restrictive use of FFP guided by clinical assessment of bleeding and VE-POCT is feasible and did not result in clinically significant haemostatic impairment. Studies should compare the clinical and cost effectiveness of empirical FFP infusions, according to current guidelines, with targeted use of FFP based on VE-POCT. CLINICAL TRIAL REGISTRATION: ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 ) (accessed July 24, 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search?query=2011-005511-11 ) (accessed July 24, 2017).

Coagulopathy and placental abruption: changing management with ROTEM-guided fibrinogen concentrate therapy.

Placental abruption may cause significant haemorrhage and coagulopathy that can progress rapidly due to simultaneous consumption and depletion of clotting factors. Plasma fibrinogen levels are predictive of further haemorrhage. Rapid detection and treatment of hypofibrinogenaemia is essential in the evolving clinical and haematological situation. The use of near-patient testing of coagulation using rotational thromboelastometry (ROTEM) allows dynamic monitoring of coagulopathy. Following the introduction of fibrinogen concentrate into our unit, a ROTEM-guided algorithm was developed for use in obstetric haemorrhage. We describe four cases of placental abruption, haemorrhage and severe coagulopathy that span the introduction of the algorithm. Three cases were associated with intrauterine death and the fourth with delivery of an extremely premature neonate. Rotational thromboelastometry was used in all cases but methods of fibrinogen replacement differ, illustrating evolving management of the condition in our unit.

Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage.

We compared blood component requirements during major obstetric haemorrhage, following the introduction of fibrinogen concentrate. A prospective study of transfusion requirements and patient outcomes was performed for 12 months to evaluate the major obstetric haemorrhage pathway using shock packs (Shock Pack phase). The study was repeated after the pathway was amended to include fibrinogen concentrate (Fibrinogen phase). The median (IQR [range]) number of blood components given was 8.0 (3.0-14.5 [0-32]) during the Shock Pack phase, and 3.0 (2.0-5.0 [0-26]) during the Fibrinogen phase (p = 0.0004). The median (IQR [range]) quantity of fibrinogen administered was significantly greater in the Shock Pack phase, 3.2 (0-7.1 [0-20.4]) g, than in the Fibrinogen phase, 0 (0-3.0 [0-12.4]) g, p = 0.0005. Four (9.5%) of 42 patients in the Shock Pack phase developed transfusion associated circulatory overload compared with none of 51 patients in the Fibrinogen phase (p = 0.038). Fibrinogen concentrate allows prompt correction of coagulation deficits associated with major obstetric haemorrhage, reducing the requirement for blood component therapy and the attendant risks of complications.

The economic benefits of cell salvage in obstetric haemorrhage.

BACKGROUND: Cell salvage is increasingly used in the management of major obstetric haemorrhage. Its financial considerations were evaluated over a 5-year period. METHOD: Cell salvage was introduced in the Liverpool Women's NHS Foundation Trust in 2006. Data were collected from all cases in which it was set-up and included the volume of blood processed and returned and whether surgery was elective or emergency. RESULTS: Between 1st January 2006 and 30th June 2011, cell salvage for collection was set-up 587 times and blood was returned in 137 patients. Total volume of blood returned was 47143mL, equivalent to 189 units of packed red cells. The return rate was higher for emergency than elective cases (P=0.03). As the use of cell salvage has extended over time to include a greater proportion of patients, return rates have decreased (P<0.0001). The volume of blood returned from cell salvage was significantly related to the estimated blood loss (P<0.00001), with a best fit line described by estimated blood loss=3.45x+454, where x was the volume of blood returned. In 2011 total costs of cell salvage were £9245 for the equivalent of 83 units of blood. At the current price of £125 per unit of allogeneic blood this would have cost £10375: a saving of £1130. No intraoperative or postoperative complications associated with cell salvage were seen. CONCLUSION: The routine use of cell salvage was associated with more salvaged blood being returned to patients, which offset the cost of collection sets when compared to the cost of using allogeneic blood. Cell salvage is an appropriate expenditure to reduce the use of allogeneic blood.

Rocuronium and sugammadex for rapid sequence induction of obstetric general anaesthesia.

BACKGROUND: Many anaesthetists use rocuronium in place of suxamethonium for rapid sequence induction (RSI). This is less common in obstetric anaesthesia as the duration of action of an effective dose of rocuronium exceeds most obstetric procedures. Sugammadex offers the possibility of rapidly reversing profound rocuronium neuromuscular blockade at the end of surgery. We aimed to determine whether rocuronium 1.2 mg/kg used for RSI in the obstetric population would provide good intubating conditions at 60 s and would be effectively reversed by sugammadex at the end of surgery. METHODS: We present a prospective series of 18 patients who received rocuronium 1.2 mg/kg at induction of anaesthesia, monitored with a train-of-four ratio (TOF)-Watch SX(®) , and reversed using sugammadex 4 mg/kg. RESULTS: The mean (95% CI) onset time of rocuronium was 71 (56-86) s, and the mean (95% CI) time to recovery of the TOF to ≥90%, after the administration of sugammadex 4 mg/kg at the end of surgery, was 86 (69-104) s. CONCLUSION: Rocuronium 1.2 mg/kg reversed by sugammadex appears to be effective in the obstetric population.

Meningitis following spinal anaesthesia - a coincidental infection?

We report a case of meningitis developing a number of days after a subarachnoid block for caesarean section. No organisms were grown but the clinical picture was suggestive of bacterial meningitis, the clinical course of which had been modified by the administration of antibiotics for presumed wound infection. The possible aetiology is discussed.

Increased ventilation requirements during obstetric general anaesthesia.

The inspiratory fresh gas flow rate (FGF) required to produce an end-tidal carbon dioxide tension (PE'CO2) of 4 kPa during general anaesthesia, neuromuscular blockade and artificial ventilation, was compared in a group of 46 obstetric patients and a matched group of 50 non-pregnant female patients. The non-pregnant patients required a mean (SD) inspiratory FGF of 77 (10.6) ml kg-1 min-1, whereas the pregnant patients required a mean FGF of 121 (24.6) ml kg-1 min-1 before delivery (in those who reached a stable state), and 109 (19.3) ml kg-1 min-1 after delivery. These represent significant (P less than 0.0001) increases of 57% and 42%, respectively, over the non-pregnant state.