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Oh’s Intensive Care Manual

Thu, 01 Jan 2026 00:00:00 GMT

Title: Oh’s Intensive Care Manual Authors: Liang J; Lawrey YT Editors: Handy JM [ed]; Venkatesh B [ed]

HYPoxic Enhancement Before Major Surgery (HYPE): A pilot randomised controlled trial of preoperative Roxadustat vs placebo in patients undergoing major surgery - Statistical Analysis Plan

Wed, 11 Mar 2026 00:00:00 GMT

Title: HYPoxic Enhancement Before Major Surgery (HYPE): A pilot randomised controlled trial of preoperative Roxadustat vs placebo in patients undergoing major surgery - Statistical Analysis Plan Authors: Toner AJ Abstract: This is a phase 2, single-centre, double-blind, placebo-controlled randomized trial to evaluate the safety and potential eZicacy of preoperative roxadustat in patients undergoing elective major noncardiac surgery. Patients take three preoperative doses of roxadustat 100mg or placebo with dose 1 four days before surgery, dose 2 two days before surgery and dose 3 on the morning of surgery.

ROTEM Guided Cryoprecipitate Dose: An Audit of Compliance and Efficacy

Title: ROTEM Guided Cryoprecipitate Dose: An Audit of Compliance and Efficacy Authors: Anthony Yap, Oscar Boag Taylor, Hawn Trinh, Coralie Williams, Keith Kelly, Catherine Downs Abstract: ROTEM Guided Cryoprecipitate Dose: An Audit of Compliance and Efficacy Anthony Yap1, Oscar Boag Taylor1,2, Hawn Trinh1,2, Coralie Williams3,4, Keith Kelly2, Catherine Downs1,2 1 UNSW School of Clinical Medicine, Sydney NSW, Australia. 2 Prince of Wales Department of Anaesthesia, SESLHD, Sydney NSW. 3 Ecology and Evolution Research Centre, UNSW, Sydney, Australia. 4 School of Mathematics and Statistics, UNSW, Sydney, Australia Background Rotational thromboelastometry (ROTEM) is a rapid viscoelastic haemostatic assay that assesses patient coagulation and guides targeted transfusion with an evidence-based algorithm1. The FIBTEM A5 parameter of a ROTEM test correlates with a patient’s blood fibrinogen level, correction of which can help to control a critical bleed2,3. To achieve this, the Randwick ROTEM algorithm’s FIBTEM step advises tiered cryoprecipitate dosing. Clinician compliance is essential to utilise the potential benefits of a ROTEM-guided transfusion, however, there is a relative lack of literature in this area. Existing ROTEM efficacy studies often do not account for compliance, obscuring the true benefits of ROTEM-guided care. This study aimed to: 1. Audit clinician compliance with the FIBTEM step of the Randwick ROTEM algorithm. 2. Assess the efficacy of the Randwick FIBTEM step at increasing FIBTEM A5 through tiered apheresis cryoprecipitate dosing recommendations. Methods This was a retrospective cross-sectional study of ROTEM tests conducted at the cardiothoracic surgical unit and cardiothoracic intensive care unit from 01 January 2024 to 13 February 2025. This Randwick ROTEM algorithm recommends a weight-adjusted apheresis cryoprecipitate dose when a critically bleeding patient’s FIBTEM A5 drops below 12mm (Figure 1). COMPLIANCE: 276 ROTEM tests met the following inclusion criteria: measured FIBTEM A5 level below 12mm, recorded patient weight (kg) and had a cryoprecipitate transfusion to the patient within 4 hours. There were 42 voluntary REDCap surveys where clinicians reported whether they believed their transfusion was algorithm-compliant. 3 dose ratio transfusion categories were defined by dividing the units of cryoprecipitatetransfused by units recommended by the algorithm. • Excessive Transfusion: >1.25 (non-compliant) • Compliant Transfusion: 0.75 - 1.25. • Insufficient Transfusion: <0.75 (non-compliant) EFFICACY: Of the 276 ROTEM tests, 108 were linked to a subsequent ROTEM test within 12 hours. Only the first pairs were analysed. A cryoprecipitate transfusion response was defined as “corrected” if the subsequent FIBTEM A5 normalised to 12mm or greater. It was defined as “non-corrected” if the FIBTEM A5 remained below 12mm. Results: Compliance Figure 2 displays the percentage proportion of transfusions that were excessively, insufficiently or compliantly dosed at various FIBTEM A5 ranges. The majority, 177/294 (60.2%), of ROTEM tests received a compliant transfusion response at the 2 locations audited. There was a strong concordance between a clinician’s belief of their compliance (subjective) with compliance as defined by the dose ratio (objective). (Figure 3) Results: Efficacy Figure 4 displays whether subsequent FIBTEM A5 measurements corrected in response to transfusion responses at the three dose ratios. Compliant transfusions led to FIBTEM A5 correction in the majority, 65.2% (45/69), of the subsequent test. No corrected FIBTEM A5 exceeded 25mm. Excessive Transfusions • FIBTEM A5 correction occurred in 92.3% (24/26) of the subsequent test. • Relative to a compliant transfusion response, the odds of FIBTEM A5 normalisation increased by 6.30 times (95% CI, 0.53 – 33.90, p = 0.013). Insufficient Transfusions • FIBTEM A5 correction occurred in only 38.5% (5/13) of the subsequent test. • Relative to a compliant transfusion response, the odds of FIBTEM A5 normalisation decreased by 0.71 times (95% CI, 0.05 – 0.92, p = 0.06). Conclusions Compliance: Randwick campus clinicians at the CTICU and CTSU were mostly compliant with their transfusions. Other studies reported lower compliance rates where the endpoint for compliance was only the correct blood product given, without consideration of the dose4. Efficacy: This study found that the FIBTEM step was effective. Compliant transfusions, using the tiered algorithm, corrected most FIBTEM A5 in a single dose intervention. Relative safety was observed as no FIBTEM A5 corrected beyond 25mm, even with excessive dosing. Future Directions: This study was limited by the small sample sizes in ROTEM tests with lower FIBTEM A5, as well as REDCap responses. To address this, the REDCap survey should be simplified and a continuing audit of the new Randwick algorithm should be conducted. Future studies should also review complications related to ROTEM usage and analyse efficacy through investigation of bleeding cessation as a clinical endpoint. The trends underpinning excessive and insufficient transfusions should be identified and targeted to improve transfusion practice. Figure 4 displays whether subsequent FIBTEM A5 measurements corrected in response to transfusion responses at the three dose ratios. Compliant transfusions led to FIBTEM A5 correction in the majority, 65.2% (45/69), of the subsequent test. No corrected FIBTEM A5 exceeded 25mm. Excessive Transfusions • FIBTEM A5 correction occurred in 92.3% (24/26) of the subsequent test. • Relative to a compliant transfusion response, the odds of FIBTEM A5 normalisation increased by 6.30 times (95% CI, 0.53 – 33.90, p = 0.013). Insufficient Transfusions • FIBTEM A5 correction occurred in only 38.5% (5/13) of the subsequent test. • Relative to a compliant transfusion response, the odds of FIBTEM A5 normalisation decreased by 0.71 times (95% CI, 0.05 – 0.92, p = 0.06). References 1. Drotarova M, Zolkova J, Belakova KM, et al. Basic Principles of Rotational Thromboelastometry (ROTEM®) and the Role of ROTEM-Guided Fibrinogen Replacement Therapy in the Management of Coagulopathies.Diagnostics (Basel). 2023;13(20):3219. Published 2023 Oct 16. doi:10.3390/diagnostics13203219 2. de Vries JJ, Veen CSB, Snoek CJM, Kruip MJHA, de Maat MPM. FIBTEM clot firmness parameters correlate well with the fibrinogen concentration measured by the Clauss assay in patients and healthy subjects.Scand J Clin Lab Invest. 2020;80(7):600-605. doi:10.1080/00365513.2020.1818283 3. Blayney A, McCullough J, Wake E, et al. Substitution of ROTEM FIBTEM A5 for A10 in trauma: an observational study building a case for more rapid analysis of coagulopathy.Eur J Trauma Emerg Surg. 2022;48(2):1077-1084. doi:10.1007/s00068-021-01652-w 4. Harish V, Postill G, Al-Haimus F, et al. Adherence to local rotational thromboelastometry recommendations in the care of trauma patients: A retrospective cohort study.Transfusion. 2025;65(9):1716-1727. doi:10.1111/trf.18349 Figure 2: Histogram Showing the Percentage Proportions of Three Dose Ratio Transfusion Categories at Various FIBTEM Ranges Figure 3: Pie Graphs Comparing Subjective and Objective Compliance Figure 4: Sankey Diagram Displaying FIBTEM A5 Correction Rates at the Three Dose Ratio Transfusion Categories

EXPEDITE CABG - Multiplate platelet function testing to decide timing of cardiac surgery for patients on platelet inhibitors: A single centre retrospective cohort study

Title: EXPEDITE CABG - Multiplate platelet function testing to decide timing of cardiac surgery for patients on platelet inhibitors: A single centre retrospective cohort study Authors: Selby, J; Saxena, A; Feddah, G; Downs, C Abstract: Background: Patients for urgent coronary artery bypass grafting (CABG) may be administered antiplatelet medications to reduce the risk of thrombotic complications. This can lead to increased risk of bleeding peri-operatively and recommended waiting periods aim to mitigate this risk (1). Multiplate® testing quantifies platelet inhibition due to drugs such as clopidogrel and ticagrelor. Many patients exhibit resistance to these drugs (2). Patients with normal platelet function despite recent drug administration may be delayed unnecessarily leading to increased hospital length of stay and cost of hospitalization in an already burdened healthcare system. Algorithms are used in many centres to identify patients who have had faster recovery of platelet function to expedite surgery sooner than the recommended waiting period (3). The Randwick Campus protocol was introduced in 2020. The cut-offs for an acceptable bleeding risk green-zone result are based on previous studies describing the predictive value of Multiplate® for excessive bleeding in CABG (4). This study had two aims: 1. To audit local utilisation of the multiplate algorithm 2. To compare the risk of post-operative bleeding and red cell transfusion in patients who had expedited surgery meeting local criteria, with those who had waited the usual waiting period. Method: Patients who underwent CABG over 42 months from 2021-2024 were audited for antiplatelet medication administration (excluding aspirin), and whether this was within the usual washout period for that medication (see algorithm). Patients on platelet inhibitors within the waiting period were defined as eligible for Multiplate®. The proportion of eligible cases who received a Multiplate® test, the result (binary green/red) and the number of days on the ward saved were collected. Hospital cost-savings were calculated based on LHD patient fees, $2838/night for a medicare-ineligible acute bed (5). Patients who met the green criterion and proceeded to surgery early were analysed for: o Primary outcome - chest tube drainage measured from chest closure to 24hr postop in ICU. o Secondary outcome - transfusion requirement for red cell (RBC) units given post-bypass prior to ICU discharge. Outcomes were indexed to patient blood volume using the Nadler equation to account for differing patient sizes. A retrospective control cohort of CABG patients in the same timeframe who had waited the prescribed number of days to offset the medication or had not been given antiplatelet drugs was collected for comparison. Results: Of a cohort of 623 CABG patients, 177 patients had received clopidogrel or ticagrelor and of these 73 patients were still within the waiting period when booked for surgery, ie clopidogrel ≤5 days (n=68) or ticagrelor ≤ 3 days (n=5). Multiplate® tests were performed in 26 cases, this was only 36% of eligible patients. Of these 26 cases, 9 had a green zone ADP,TRAP and ASPI Multiplate® result despite recent antiplatelet drug. All 9 patients proceeded to expedited surgery. The number of nights in hospital saved over the audit period was 14, equivalent to approximately $40 000 (14*$2838/night). The time-based control group consisted of 548 patients who had received neither drug, or had waited the recommended time-period. For the primary outcome of 24hr chest drain output: o Multiplate® group mean (standard deviation) was 138 (67) ml/L (median 123ml, interquartile range (IQR) 112ml) o Control group mean was 129 (73) ml/L (median 118ml, IQR 64ml). For the secondary outcome of RBC units: o Multiplate® group mean was 0.3 (0.28) u/L (median 0.4, IQR 0.59), o Control group mean was 0.2 (0.36) u/L (median 0, IQR 0.2). Conclusion: In our institution the rate of Multiplate® testing (36%) is currently less than ideal. If testing rates were to improve, it is feasible that many more patients would be identified and significantly more cases could be expedited. Although this is a small sample cohort, the central tendencies between groups do not appear clinically different given the small difference in mean/median of primary and secondary outcomes. There was greater dispersion of outcomes in the Multiplate® group (higher SD and IQR) for both outcomes, however this is limited by the caveat of a small sample size (9 cases). These data are encouraging and form the basis for a proposed multi-centre prospective RCT to clarify if expedited surgery has non-inferior outcomes. If non-inferiority is demonstrated, this would translate to multiple benefits for both patients and the healthcare system, including reduced risk of preoperative complications, nosocomial infections, length of stay and cost of hospitalization.