Efficacy and safety of tranexamic acid in patients undergoing thoracic surgery: a systematic review and PRIMSA-compliant meta-analysis.

OBJECTIVES: Perioperative bleeding poses a significant issue during thoracic surgery. Tranexamic acid (TXA) is one of the most commonly used antifibrinolytic agents for surgical patients. The purpose of the current study was designed to investigate the efficacy and safety of TXA in patients undergoing thoracic surgery. METHODS: An extensive search of PubMed, Web of Science (WOS), Cochrane Library (trials), Embase, OVID, China National Knowledge Infrastructure (CNKI), Wanfang, and VIP electronic databases was performed to identify studies published between the inception of these databases and March 2023. The primary outcomes included perioperative blood loss and blood transfusions. Secondary outcomes of interest included the length of stay (LOS) in hospital and the incidence of thromboembolic events. Weighted mean differences (WMDs) or odds ratios (OR) with 95% confidence intervals (CI) were used to determine treatment effects for continuous and dichotomous variables, respectively. RESULTS: Five qualified studies including 307 thoracic surgical patients were included in the current study. Among them, 65 patients were randomly allocated to the group receiving TXA administration (the TXA group); the other 142 patients were assigned to the group not receiving TXA administration (the control group). TXA significantly reduced the quantity of hemorrhage in the postoperative period (postoperative 12h: WMD = -81.90 ml; 95% CI: -139.55 to -24.26; P = 0.005; postoperative 24h: WMD = -97.44 ml; 95% CI: -121.44 to -73.44; P< 0.00001); The intraoperative blood transfusion volume (WMD = -0.54 units; 95% CI: -1.06 to -0.03; P = 0.04); LOS in hospital (WMD = -0.6 days; 95% CI: -1.04 to -0.16; P = 0.008); And there was no postoperative thromboembolic event reported in the included studies. CONCLUSIONS: The present study demonstrated that TXA significantly decreased blood loss within 12 and 24 hours postoperatively. A qualitative review did not identify elevated risks of safety outcomes such as thromboembolic events. It also suggested that TXA administration was associated with shorter LOS in hospital as compared to control. To validate this further, additional well-planned and adequately powered randomized studies are necessary.

Efficacy and safety of prophylactic balloon occlusion in the management of placenta accreta spectrum disorder: a retrospective cohort study.

OBJECTIVE: Placenta accreta spectrum disorder (PAS) is a serious obstetric complication associated with significant maternal morbidity and mortality. Prophylactic balloon occlusion (PBO), as an intravascular interventional therapies, has emerged as a potential management strategy for controlling massive hemorrhage in patients with PAS. However, current evidence about the clinical application of PBO in PAS patients are still controversial. This study aimed to evaluate the effectiveness and safety of PBO in the management of PAS. METHODS: A retrospective cohort study including PAS patients underwent cesarean delivery was conducted in a tertiary hospital from January 2015 to March 2022. Included PAS patients were further divided into balloon and control groups by whether PBO was performed. Groups were compared for demographic characteristics, intraoperative and postoperative parameters, maternal and neonatal outcomes, PBO-related complication and follow up outcomes. Additionally, multivariate-logistic regression analysis was performed to determine the definitive associations between PBO and risk of massive hemorrhage and hysterectomy. RESULTS: A total of 285 PAS patients met the inclusion criteria were included, of which 57 PAS patients underwent PBO (PBO group) and 228 women performed cesarean section (CS) without PBO (control group). Irrespective of the differences of baseline characteristics between the two groups, PBO intervention did not reduce the blood loss, hysterectomy rate and postoperative hospital stay, but it prolonged the operation time and increased the cost of hospitalization (All P < 0.05) Additionally, there were no significant differences in postoperative complications, neonatal outcomes, and follow-up outcomes(All P > 0.05). In particular, patients undergoing PBO were more likely to develop the venous thrombosis postoperatively (P = 0.001). However, multivariate logistic regression analysis showed that PBO significantly decreased the risk of massive hemorrhage (OR 0.289, 95%CI:0.109-0.766, P = 0.013). The grade of PAS and MRI with S2 invasion were the significant risk factors affecting massive hemorrhage(OR:6.232 and OR:5.380, P<0.001). CONCLUSION: PBO has the potential to reduce massive hemorrhage in PAS patients undergoing CS. Obstetricians should, however, be aware of potential complications arising from the PBO. Additionally, MRI with S2 invasion and PAS grade will be useful to identify PAS patients who at high risk and may benefit from PBO. In brief, PBO seem to be a promising alternative for management of PAS, yet well-designed randomized controlled trials are needed to convincingly demonstrate its benefits and triage the necessity of PBO.

The efficacy and safety of different does of intravenous tranexamic acid on blood loss in fresh foot and ankle fractures: a prospective, randomized controlled study.

BACKGROUND: There are a few studies on the effectiveness and safety of intravenous administration of tranexamic acid(TXA) in patients who underwent foot and ankle surgery, especially for preoperative hidden blood loss in patients with freshfoot and ankle fractures. Thus, the aim of this study was to investigate whether intravenous administration of different doses of TXA can effectively reduce perioperative blood loss and blood loss before surgery and to determine its safety. METHODS: A total of 150 patients with fresh closed foot and ankle fractures from July 2021 to July 2023 were randomly divided into a control group (placebo controlled [PC]), standard-dose group (low-dose group [LD], 1 g/24 h; medium-dose group [MD], 2 g/24 h), and high-dose group (HD, 3 g/24 h; ultrahigh-dose group [UD], 4 g/24 h). After admission, all patients completed hematological examinations as soon as possible and at multiple other time points postsurgery. RESULTS: There was a significant difference in the incidence of hidden blood loss before the operation between the TXA group and the control group, and the effect was greater in the overdose groups than in the standard-dose groups. There were significant differences in surgical blood loss (intraoperative and postoperative), postoperative HGB changes, and hidden blood loss among the groups. The TXA groups showed a significant decrease in blood loss compared to that of the control group, and the overdose groups had a more significant effect than the standard-dose groups. A total of 9 patients in the control group had early wound infection or poor healing, while only 1 patient in the other groups had this complication, and the difference among the groups was significant. No patients in any group suffered from late deep wound infection, cardiovascular or cerebrovascular events or symptomatic VTE. CONCLUSION: This is the first study on whether TXA can reduce preoperative hidden blood loss in patients with freshfoot and ankle fractures. In our study, on the one hand, intravenous application of TXA after foot and ankle fractures as soon as possible can reduce preoperative blood loss and postoperative blood loss. On the other hand, TXA can also lower wound complications, and over-doses of TXA are more effective than standard doses. Moreover, overdoses of TXA do not increase the incidence of DVT.

Comparison of the clinical outcomes between proximal femoral nail anti-rotation with cement enhancement and hemiarthroplasty among elderly osteoporotic patients with intertrochanteric fracture.

BACKGROUND: The proximal femoral nail anti-rotation (PFNA) with cement enhancement enhances the anchorage ability of internal fixation in elderly with osteoporotic intertrochanteric fracture. However, whether it is superior to hemiarthroplasty is still controversial. The present study aimed to determine which treatment has better clinical outcomes among older patients. METHODS: We retrospectively analyzed 102 elderly patients with osteoporosis who developed intertrochanteric fractures and underwent PFNA combined with cement-enhanced internal fixation (n = 52, CE group), and hemiarthroplasty (n = 50, HA group) from September 2012 to October 2018. All the intertrochanteric fractures were classified according to the AO/OTA classification. Additionally, the operative time, intraoperative blood loss, intraoperative and postoperative blood transfusion rates, postoperative weight-bearing time, hospitalization time, Barthel Index of Activities Daily Living, Harris score of hip function, visual analog (VAS) pain score, and postoperative complications were compared between the two groups. RESULTS: The CE group had significantly shorter operative time, lesser intraoperative blood loss, lower blood transfusion rate, and longer postoperative weight-bearing time than the HA group. The CE group had lower Barthel's Index of Activities of Daily Living, lower Harris' score, and higher VAS scores in the first and third months after surgery than the HA group, but no difference was observed between the two groups from 6 months to 12 months. There was no significant difference in the total post-operative complications between the two groups. CONCLUSION: The use of PFNA combined with a cement-enhanced internal fixation technique led to shorter operative time and lesser intraoperative blood loss and trauma in elderly patients as compared to HA.

The Efficacy of Tranexamic Acid in Reducing Perioperative Drainage in Cardiac Surgery with Cardiopulmonary Bypass.

INTRODUCTION: Although cardiopulmonary bypass procedures remain a critical treatment option for heart disease, they come with risks, including hemorrhage. Tranexamic acid is known to reduce morbidity and mortality in surgical hemorrhage. OBJECTIVE: This study aimed to evaluate the efficacy of tranexamic acid, which is routinely used to treat hemorrhage, in decreasing the amount of intraoperative and postoperative drainage. METHOD: A total of 80 patients who underwent cardiac surgery with cardiopulmonary bypass were included in this retrospective study. Forty patients who received tranexamic acid during the operation were assigned to Group 1, while 40 patients who did not receive tranexamic acid were assigned to Group 2. Patient data were collected from the hospital computer system and/or archive records after applying exclusion criteria, and the data were recorded. Statistical analyses were then performed to compare the data. RESULTS: Age, sex, height, weight, body surface area, flow, and ejection fraction percentages, preoperative hematological parameters, and intraoperative variables (except tranexamic acid) were similar between the groups (P>0.05). However, there were statistically significant differences between the groups in terms of intraoperative (through the heart-lung machine) and postoperative red blood cell transfusion rates, intraoperative and postoperative bleeding drainage amounts, as well as postoperative hematocrit, hemoglobin, platelet, and red blood cell levels (P<0.05). CONCLUSION: We concluded that intraoperative and postoperative use of tranexamic acid in patients who underwent coronary artery bypass grafting with cardiopulmonary bypass has positive effects on hematological parameters, reducing blood product use, and bleeding drainage amount.

A Comprehensive Patient Blood Management Program During Cardiopulmonary Bypass in Patients Over 60 Years of Age.

Purpose: There is currently no consensus on the most appropriate blood transfusion strategy for older adults undergoing cardiovascular surgery. We aimed to investigate the potential benefits of the patient blood management (PBM) program specifically for advanced age patients, and to evaluate the relationship of age and PBM in cardiovascular surgery. Patients and Methods: We collected data from patients over 60 years old who underwent on-pump cardiovascular surgery. We compared transfusion and clinical outcomes between the pre-PBM and post-PBM groups using a propensity score matching method. Then, we conducted a subgroup analysis within the original cohort, specifically focusing on patients aged of 75 and above with multivariable adjusted models. Results: Data of 9703 older adults were analyzed. Red blood cell (RBC) transfusion rates during cardiopulmonary bypass (CPB) (31.6% vs 13.1%, P<0.001), during the operation (50.8% vs 39.0%, P<0.001) and after the operation (5.6% vs 3.1%, P<0.001) were significantly reduced, and mortality and the risk of some adverse events were also reduced after the PBM. Subgroup analysis showed that there was no interaction between age and PBM, and advanced age (over age 75) did not modify the effect of PBM program in reducing RBC transfusion (Pinteraction=0.245), on mortality (Pinteration=0.829) and on certain complications. Conclusion: The comprehensive PBM program could reduce RBC transfusion without adverse outcomes in older patients undergoing CPB. Even patients over age 75 may benefit from a more stringent transfusion indication. Comprehensive blood conservation measures should be applied to optimize the blood management for older patients.

In Nordic countries 30-day mortality rate is half that estimated with EuroSCORE II in high-risk adult patients given aprotinin and undergoing mainly complex cardiac procedures.

Objectives. To describe current on- (isolated coronary arterty bypass grafting, iCABG) and off-label (non-iCABG) use of aprotinin and associated safety endpoints in adult patients undergoing high-risk cardiac surgery in Nordic countries. Design. Data come from 10 cardiac surgery centres in Finland, Norway and Sweden participating in the European Nordic aprotinin patient registry (NAPaR). Results. 486 patients were given aprotinin between 2016 and 2020. 59 patients (12.1%) underwent iCABG and 427 (87.9%) non-iCABG, including surgery for aortic dissection (16.7%) and endocarditis (36.0%). 89.9% were administered a full aprotinin dosage and 37.0% were re-sternotomies. Dual antiplatelet treatment affected 72.9% of iCABG and 7.0% of non-iCABG patients. 0.6% of patients had anaphylactic reactions associated with aprotinin. 6.4% (95 CI% 4.2%-8.6%) of patients were reoperated for bleeding. Rate of postoperative thromboembolic events, day 1 rise in creatinine >44µmol/L and new dialysis for any reason was 4.7% (95%CI 2.8%-6.6%), 16.7% (95%CI 13.4%-20.0%) and 14.0% (95%CI 10.9%-17.1%), respectively. In-hospital mortality and 30-day mortality was 4.9% (95%CI 2.8%-6.9%) and 6.3% (95%CI 3.7%-7.8%) in all patients versus mean EuroSCORE II 11.4% (95%CI 8.4%-14.0%, p < .01). 30-day mortality in patients undergoing surgery for aortic dissection and endocarditis was 6.2% (95%CI 0.9%-11.4%) and 6.3% (95%CI 2.7%-9.9%) versus mean EuroSCORE II 13.2% (95%CI 6.1%-21.0%, p = .11) and 14.5% (95%CI 12.1%-16.8%, p = .01), respectively. Conclusions. NAPaR data from Nordic countries suggest a favourable safety profile of aprotinin in adult cardiac surgery.

Tranexamic acid versus adrenaline-soaked pledgets for the reduction of intraoperative bleeding in functional endoscopic sinus surgery.

OBJECTIVE: Aim: To examine the impact of locally applied tranexamic acid and adrenaline, separately and in combination, on intraoperative blood loss and surgical field quality during functional endoscopic sinus surgery. PATIENTS AND METHODS: Materials and Methods: The study involved 40 patients with chronic rhinosinusitis. They were divided into two groups. Group I received adrenaline alone in one side and a mixture of adrenaline and tranexamic acid in the other side. Group II received adrenaline alone in one side and tranexamic acid in the otherside. Parameters like surgery time, blood loss, and surgical field quality were studied. RESULTS: Results: In Group I, the combination of adrenaline and tranexamic acid significantly reduced blood loss and enhanced surgical field quality compared to adrenaline alone. In Group II, adrenaline outperformed tranexamic acid in shortening surgery duration and improving surgical field quality. However, there was no significant difference in blood loss reduction between adrenaline and tranexamic acid. CONCLUSION: Conclusions: The study concluded that tranexamic acid is less effective than adrenaline when introduced as topical intranasal pledgets in both decreasing the time needed for the surgery and improving the subjective satisfaction of the surgeon while there is no significant difference regarding decreasing intraoperative blood loss. The mixture of adrenaline and tranexamic acid pledgets are more effective than adrenaline-only pledgets in terms of decreasing the intraoperative blood loss and improving the surgeon's satisfaction with no significant difference regarding the time needed for the surgery.

Comparison of blood loss between intra-articular microporous polysaccharide hemospheres powder and tranexamic acid following primary total knee arthroplasty.

Total knee arthroplasty (TKA) is associated with substantial blood loss and tranexamic acid (TXA) effectively reduces postoperative bleeding. Although it is known that there is no difference between intravenous or intra-articular (IA) injection, the general interest is directed towards topical hemostatic agents regarding thromboembolic events in high-risk patients. This study aimed to compare the blood conservation effects of IA MPH powder and TXA in patients undergoing primary TKA. We retrospectively analyzed 103 patients who underwent primary TKA between June 2020 and December 2021. MPH powder was applied to the IA space before capsule closure (MPH group, n = 51). TXA (3 g) was injected via the drain after wound closure (TXA group, n = 52). All patients underwent drain clamping for three postoperative hours. The primary outcome was the drain output, and the secondary outcomes were the postoperative hemoglobin (Hb) levels during the hospitalization period and the perioperative blood transfusion rates. An independent Student's t-test was used to determine differences between the two groups. The drain output in the first 24 h after surgery was significantly higher in the MPH group than in the TXA group. The postoperative Hb levels were significantly lower in the MPH group than in the TXA group. In patients with simultaneous bilateral TKA, there was a significant difference in the blood transfusion volumes and the rates between groups. It is considered that IA MPH powder cannot replace IA TXA because of an inferior efficacy in reducing blood loss and maintaining postoperative Hb levels in the early postoperative period after primary TKA. Moreover, in the case of simultaneous bilateral TKA, we do not recommend the use of IA MPH powder because it was notably less effective in the field of transfusion volume and rate.

Optimised fast-track protocols in total knee arthroplasty determine shorter hospitalisation time and lower perioperative/postoperative complications.

PURPOSE: This literature review aims to present evidence-based clinical recommendations for the eight most debated topics related to perioperative management in total knee arthroplasty: counselling, prehabilitation, transfusion risk, tranexamic acid, drainage, analgesia, urinary catheter and compression stockings. METHODS: A multidisciplinary team conducted a systematic review on these topics. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for the literature review and result presentation. The research encompassed articles from 1 January 2009 to 28 February 2023, retrieved through the MEDLINE database via PubMed, Embase database and Cochrane Library. RESULTS: Forty-five articles were selected. Preoperative counselling has limited evidence for its impact on postoperative outcomes; yet, it can help alleviate surgery-related anxiety and manage postoperative symptoms. Prehabilitation can also prepare patients for surgery, reducing hospital stays and improving postsurgery functionality. Numerous studies suggest that preoperative Hb levels are independently linked to transfusion risk, with a recommended level of 13 g/dL. Combining intravenous and local tranexamic acid administration is strongly advised to reduce perioperative blood loss, while drainage after primary total knee arthroplasty offers no functional advantages. Employing a multimodal analgesia approach yields better results with reduced opioid usage. Indwelling urinary catheters provide no benefit and avoiding them can lower the risk of urinary tract infections. As for compression stockings, there is insufficient evidence in the literature to support their efficacy in preventing venous thromboembolism. CONCLUSION: The best-track protocol has demonstrated its efficacy in reducing hospitalisation time and perioperative/postoperative complications. It is success relies on a collaborative, resource-adaptive approach led by a multidisciplinary team. Both patients and hospitals benefit from this approach, as it enhances care quality and lowers costs. Several studies have highlighted the significance of a patient-centred approach in achieving high-quality care. Creating a novel treatment protocol could be a prospective goal in the near future. LEVEL OF EVIDENCE: Level III.

Aspin: neurosurgical aspirin intervention prognostic study - perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial.

RATIONALE: Aspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events. OBJECTIVE: The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared with the current policy of perioperative discontinuation of aspirin. STUDY DESIGN: A randomized controlled trial with two parallel groups of 277 cases (554 in total). STUDY POPULATION: Patients undergoing low complex lumbar spinal surgery and using aspirin. All patients are aged >18 years. INTERVENTION: Peri-operative continuation of aspirin. STUDY OUTCOMES: Primary study outcome: composite of the following bleeding complications: Neurological deterioration as a result of hemorrhage in the surgical area with cauda and/or nerve root compression. Post-surgical anemia with hemoglobin level lower than 5 mmol/l, requiring transfusion. Subcutaneous hematoma leading to wound leakage and pain higher than NRS=7. Major and/or minor hemorrhage in any other body system according to the definition of the International Society on Thrombosis and Haemostasis bleeding scale. Secondary study outcomes: Each of the individual components of the primary outcome Absolute mean difference in operative blood loss between the study arms Thrombo-embolic-related complications: Myocardial infarction Venous thromboembolism Stroke Arterial thromboembolism FURTHER STUDY OUTCOMES: Anticoagulant treatment satisfaction by the Anti-Clot Treatment Scale (ACTS) and general health by the Patient-Reported Outcomes Measurement Information System (PROMIS Global-10) in the pre- and postoperative phase. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study imposes no additional risk to patients. Currently, there is no consensus on whether or not aspirin should be discontinued before cranial or spinal surgery. Currently, aspirin is typically discontinued in cranial and spinal surgery, because of a potential increased risk of hemorrhagic complication. An argument not based on a clinical trial. However, this policy might delay surgical procedures or carry the risk of resulting in an increase in cardiac and neurologic thrombotic perioperative events. It is unclear if the possibility of an increase in hemorrhage-related complications outweighs the risk of an increase in cardiac and neurologic thrombotic perioperative events. Furthermore, the Data Safety Monitoring Board (DSMB) will be asked for safety analysis by monitoring the study. There are no further disadvantages to participating in this study. Outcome measurements are recorded during admission and regular outpatient visits, and thus, do not require additional visits to the hospital.

Impact of intraosseous regional administration of tranexamic acid in total knee arthroplasty on perioperative blood loss: a protocol for a randomised controlled trial.

INTRODUCTION: Total knee arthroplasty (TKA) is a common surgical intervention to treat joint diseases. However, TKA is associated with significant blood loss. Tranexamic acid (TXA) has been used to reduce perioperative bleeding and postoperative blood transfusion. This study aims to explore the effectiveness and safety of intraosseous regional administration (IORA) of TXA in TKA and compare differences in perioperative blood loss between IORA of TXA, intravenous infusion of TXA, and combined IORA and intravenous infusion of TXA. METHODS AND ANALYSIS: This randomised controlled trial will enrol 105 patients with osteoarthritis who meet the inclusion criteria for unilateral TKA. Patients were randomly divided into three groups using the random number table method. Group A received 1.0 g of TXA via IORA, group B received 1.0 g of TXA via intravenous infusion 15 min prior to the tourniquet release, and group C received both IORA of 1.0 g of TXA and intravenous infusion of 1.0 g of TXA. The primary outcome measure is perioperative total blood loss. Secondary outcomes include bleeding events, venous thromboembolism events, inflammation reactions, other complications and knee function assessments. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Peking Union Medical College Hospital and registered in the Chinese Clinical Trial Registry. Informed consent will be obtained from all the patients before enrolment. The trial will be conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The results of this study will be disseminated through peer-reviewed publications, conference presentations and social media platforms. The findings will provide valuable insights into the use of IORA of TXA in TKA and may lead to the development of new strategies for perioperative blood management in joint replacement surgery. TRIAL REGISTRATION NUMBER: The Ethics Committee of Peking Union Medical College Hospital (approval number: K2371); Chinese Clinical Trial Registry (trial registration number: ChiCTR2200066293).

Use of Aprotinin versus Tranexamic Acid in Cardiac Surgery Patients with High-Risk for Excessive Bleeding (APACHE) trial: a multicentre retrospective comparative non-randomized historical study.

OBJECTIVES: Following the reintroduction of aprotinin into the European market, the French Society of Cardiovascular and Thoracic Anaesthesiologists recommended its prophylactic use at half-dose for high-risk cardiac surgery patients. We examined whether the use of aprotinin instead of tranexamic acid could significantly reduce severe perioperative bleeding. METHODS: This multicentre, retrospective, historical study included cardiac surgery patients treated with aprotinin or tranexamic acid between December 2017 and September 2020. The primary efficacy end point was the severe or massive perioperative bleeding (class 3-4 of the universal definition of perioperative bleeding). The safety secondary end points included the occurrence of thromboembolic events and all-cause mortality within 30 days after surgery. RESULTS: Among the 693 patients included in the study, 347 received aprotinin and 346 took tranexamic acid. The percentage of patients with severe or massive bleeding was similar in the 2 groups (42.1% vs 43.6%, Adjusted odds ratio [ORadj] = 0.87, 95% confidence interval: 0.62-1.23, P = 0.44), as was the perioperative need for blood products (81.0% vs 83.2%, ORadj = 0.75, 95% confidence interval: 0.48-1.17, P = 0.20). However, the median (Interquartile range) 12 h postoperative blood loss was significantly lower in the aprotinin group (383 ml [241-625] vs 450 ml [290-730], P < 0.01). Compared to tranexamic acid, the intraoperative use of aprotinin was associated with increased risk for thromboembolic events (adjusted Hazard ratio 2.30 [95% Cl: 1.06-5.30]; P = 0.04). CONCLUSIONS: Given the modest reduction in blood loss at the expense of a significant increase in thromboembolic adverse events, aprotinin use in high-risk cardiac surgery patients should be based on a carefully considered benefit-risk assessment.

Early Acetabular Fracture Repair Through an Anterior Approach Is Associated With Increased Blood Loss.

OBJECTIVES: To determine whether the timing of acetabular fracture fixation through an anterior approach influences estimated and calculated perioperative blood loss. DESIGN: Retrospective cohort study. SETTING: Level 1 trauma center from 2013 to 2021. PATIENT SELECTION CRITERIA: Patients aged ≥18 years treated with acetabular fracture fixation through an anterior-based approach. OUTCOME MEASURES AND COMPARISONS: The primary outcome was calculated blood loss (CBL). Secondary outcomes were estimated blood loss reported by surgeon and anesthesia, and blood transfusion requirements. Comparisons of blood loss were made at discrete postinjury time thresholds (24, 36, and 48 hours) and on a continuous basis. RESULTS: One hundred eight patients were studied. The mean age was 65 years, and 73% of patients were male. Earlier fixation of acetabular fractures resulted in greater CBL and estimated blood loss (surgeon and anesthesia) compared with later fixation when analyzed on a continuum and at specific time points (24, 36, and 48 hours). Mean CBL in patients treated earlier (<48 hours, 2539 ± 1194 mL) was significantly greater than those treated later (≥48 hours, 1625 ± 909 mL; P < 0.001). Fracture repair before 48 hours postinjury was associated with a 3 times greater risk of >2000 mL of CBL ( P = 0.006). This did not result in differences in transfusion rates between groups at 24 hours ( P = 0.518), 36 hours ( P = 1.000), or 48 hours ( P = 0.779). CONCLUSIONS: Delaying fixation of acetabular fractures treated through an anterior approach for 48 hours postinjury may significantly reduce perioperative blood loss. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.

BACKGROUND: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. OBJECTIVE: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. STUDY DESIGN: The study is a double-blind randomized controlled trial. METHODS: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. RESULTS: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. CONCLUSION: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363.

Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial.

BACKGROUND: Oral as compared to intravenous tranexamic acid (TXA) is an attractive option, in terms of cost and safety, to reduce blood loss and transfusion in total hip arthroplasty. Exclusion criteria applied in the most recent randomised trials may have limited the generalisability of oral tranexamic acid in this indication. Larger and more inclusive studies are needed to definitively establish oral administration as a credible alternative to intravenous administration. OBJECTIVES: To assess the noninferiority of oral to intravenous TXA at reducing intra-operative and postoperative total blood loss (TBL) in primary posterolateral approached total hip arthroplasty (PLTHA). DESIGN: Noninferiority, single centre, randomised, double-blind controlled study. SETTING: Patients scheduled for primary PLTHA. Data acquisition occurred between May 2021 and November 2022 at the University Hospital of Liège, Belgium. PATIENTS: Two hundred and twenty-eight patients, randomised in a 1 : 1 ratio from a computer-generated list, completed the trial. INTERVENTIONS: Administration of 2 g of oral TXA 2 h before total hip arthroplasty and 4 h after incision (Group oral) was compared to the intravenous administration of 1 g of TXA 30 min before surgery and 4 h after incision (Group i.v.). MAIN OUTCOME MEASURES: TBL (measured intra-operative and drainage blood loss up to 48 h after surgery, primary outcome), decrease in haemoglobin concentration, D-Dimer at day 1 and day 3, transfusion rate (secondary outcomes). RESULTS: Analyses were performed on 108 out of 114 participants (Group i.v.) and 104 out of 114 participants (Group oral). Group oral was noninferior to Group i.v. with regard to TBL, with a difference between medians (95% CI) of 35 ml (-103.77 to 33.77) within the noninferiority margins. Median [IQR] of estimated TBL was 480 ml [350 to 565] and 445 ml [323 to 558], respectively. No significant interaction between group and time was observed regarding the evolution of TBL and haemoglobin over time. CONCLUSIONS: TXA as an oral premedication before PLTHA is noninferior to its intravenous administration regarding peri-operative TBL. TRIAL REGISTRATION: European Clinical Trial Register under EudraCT-number 2020-004167-29 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004167-29/BE ).

Expert panel recommendations for topical hemostatic agent use in varied bleeding sites and situations during neuro-spine surgeries.

Intraoperative bleeding poses a substantial challenge, particularly in neuro-spine surgeries leading to complications such as hematomas, infections, and hemodynamic instability. Despite their proven efficacy, use of topical hemostatic agents (THAs) lacks comprehensive published literature and guidelines particularly in the Indian setting. The present study provides the first-ever Indian expert panel recommendations for effective adjunct THA use in different intraoperative bleeding sites and situations in neuro-spine surgeries. A comprehensive approach, encompassing a literature review, followed by experience sharing in a meeting using a survey helped integrate expert opinions in the form of practical algorithms to guide THA selection. Our survey results revealed a strong inclination towards specific THAs, flowable gelatin + thrombin being choice of THA for difficult to access and problematic bleeding situations during tumor removal/resection, transsphenoidal hypophysectomy and skull-based procedures. Both oxidized regenerated cellulose (ORC)/Fibrillar and flowable gelatin + thrombin were recommended for continuous oozing. ORC/Fibrillar was preferred for arteriovenous and cavernous malformations. This expert-panel guidance on THA use aims to optimize hemostat use practices and improve surgical outcomes in neuro-spine surgery.