Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX).

BACKGROUND: Despite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss. METHODS: The main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation. DISCUSSION: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process. TRIAL REGISTRATION: EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).

Early identification and conservative treatment of postpartum hemorrhage in the lower uterine segment after vaginal delivery.

OBJECTIVE: This study examined the efficacy of pulling down the cervix and packing it in the vaginal fornix (PC-PVF) on postpartum hemorrhage in the lower uterine segment (PPH-LUS). METHODS: All cases of PPH-LUS after vaginal delivery at two tertiary hospitals between January 2019 and December 2022 were retrospectively investigated. Patients treated successfully with conservative measures were divided into routine treatment only (40 patients), routine treatment + early PC-PVF (33 patients), and routine treatment + late PC-PVF (51 patients) groups. Routine treatment consisted of uterine massage, uterotonics, and tranexamic acid administration. The therapeutic effect was evaluated by comparing the volume and rate of bleeding within 24 h after delivery. RESULTS: A total of 124 patients were treated conservatively, except for three patients who underwent laparotomy for hemostasis after PC-PVF failed for incomplete rupture of the lower uterine segment. The efficacy of treatment was 44% (40/91) for routine treatment only and 100% when combined with PC-PVF for PPH-LUS. There was no significant difference in maternal age, gestational week, neonatal weight, and Apgar score. But the total blood loss in the conventional treatment + early PC-PVF group (657.27 ml ± 131.61 ml) was significantly lower than that in the other two groups, which was 847.13 ml ± 250.37 ml(p < .01) and 1040.78 ml ± 242.70 ml (p < .01), respectively. The bleeding rate in the routine treatment + early PC-PVF group decreased significantly after tamponade. CONCLUSIONS: PC-PVF is a safe and effective treatment for PPH-LUS. Early identification of PPH-LUS and prompt application of PC-PVF can effectively reduce blood loss after vaginal delivery.

Postpartum hemorrhage is a serious threat to maternal safety and remains to be the leading cause of maternal death. At present, there is a lack of early identification and targeted conservative treatment of PPH-LUS after vaginal delivery. Innovations for the treatment of PPH-LUS are still greatly needed because, with currently available management strategies, there is still inconsistency in outcomes, increased risk of complications, and limited access in primary hospitals. Based on clinical data statistics and comparison, it is proved that PC-PVF is a simple, rapid, and noninvasive method for the treatment of PPH-LUS after vaginal delivery in this study. Because of its simple technical requirements, easily accessible materials, and low cost, PC-PVF is suitable for hospitals at all levels.

Evaluation of the use of tranexamic acid in the postoperative period in patients with scoliosis undergoing posterior fusion.

Scoliosis is the most prevalent type of spinal deformity, with a 2-3% prevalence in the general population. Moreover, surgery for scoliotic deformity may result in severe blood loss and, consequently, the need for blood transfusions, thereby increasing surgical morbidity and the rate of complications. Several antifibrinolytic drugs, such as tranexamic acid, have been regarded as safe and effective options for reducing blood loss. Therefore, the present study aimed to analyse the effectiveness of this drug for controlling bleeding when used intraoperatively and in the first 48 h after surgery. A prospective randomized study of a cohort of patients included in a mass event for scoliosis treatment using PSF was performed. Twenty-eight patients were analysed and divided into two groups: 14 patients were selected for intraoperative and postoperative use of tranexamic acid (TXA), and the other 14 were selected only during the intraoperative period. The drainage bleeding rate, length of hospital stay, number of transfused blood units, and rate of adverse clinical effects were compared. All the patients involved had similar numbers of fusion levels addressed and similar scoliosis profiles. The postoperative bleeding rate through the drain did not significantly differ between the two groups (p > 0.05). There was no significant difference in the number of transfused blood units between the groups (p = 0.473); however, in absolute numbers, patients in the control group received more transfusions. The length of hospital stay was fairly similar between the groups, with no statistically significant difference. Furthermore, the groups had similar adverse effects (p = 0.440), with the exception of nausea and vomiting, which were twice as common in the TXA group postoperatively than in the control group. No significant differences were found in the use of TXA during the first 48 postoperative hours or in postoperative outcomes.

Tranexamic acid reduces perioperative blood transfusions following open radical cystectomy - a propensity-score matched analysis.

PURPOSE: Radical cystectomy is associated with bleeding and high transfusion rates, presenting challenges in patient management. This study investigated the prophylactic use of tranexamic acid during radical cystectomy. METHODS: All consecutive patients treated with radical cystectomy at a tertiary care university center were included from a prospectively maintained database. After an institutional change in the cystectomy protocol patients received 1 g of intravenous bolus of tranexamic acid as prophylaxis. To prevent bias, propensity score matching was applied, accounting for differences in preoperative hemoglobin, neoadjuvant chemotherapy, tumor stage, and surgeon experience. Key outcomes included transfusion rates, complications, and occurrence of venous thromboembolism. RESULTS: In total, 420 patients were included in the analysis, of whom 35 received tranexamic acid. After propensity score matching, 32 patients and 32 controls were matched with regard to clinicopathologic characteristics. Tranexamic acid significantly reduced the number of patients who received transfusions compared to controls (19% [95%-Confidence interval = 8.3; 37.1] vs. 47% [29.8; 64.8]; p = 0.033). Intraoperative and postoperative transfusion rates were lower with tranexamic acid, though not statistically significant (6% [1.5; 23.2] vs. 19% [8.3; 37.1], and 16% [6.3; 33.7] vs. 38% [21.9; 56.1]; p = 0.257 and p = 0.089, respectively). The occurrence of venous thromboembolism did not differ significantly between the groups (9% [2.9; 26.7] vs. 3% [0.4; 20.9]; p = 0.606). CONCLUSION: Prophylactic tranexamic administration, using a simplified preoperative dosing regimen of 1 g as a bolus, significantly lowered the rate of blood transfusion after cystectomy. This exploratory study indicates the potential of tranexamic acid in enhancing outcomes of open radical cystectomy.

Efficacy of topical tranexamic acid soaked absorbable gelfoam in relieving post-extraction pain in warfarin patients: a randomized, triple-blinded, split-mouth, active-controlled clinical trial.

BACKGROUND: Warfarin patients who need dental extraction face the problem of bleeding and no sufficient hemostasis results in dry socket and postoperative pain. This study aimed to evaluate and compare the efficacy of the topical application of tranexamic acid-soaked absorbable Gelfoam (TXA-Gel) and saline-soaked absorbable Gelfoam (saline-Gel) in relieving postoperative pain following bilateral simple extraction of permanent mandibular molars in warfarin patients. METHODS: This was a randomized, triple-blinded, split-mouth, active-controlled clinical trial. It was performed at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Damascus University, between November 2021 and October 2023. 60 bilateral permanent mandibular molars, which were indicated for simple extraction in 30 warfarin patients randomly assigned into two groups according to the topical hemostatic agents after extraction used: Group 1: control group, saline-Gel (n = 30). Group 2: TXA-Gel (n = 30). A simple randomization method was performed by flipping a coin. The primary outcome measure was the visual analogue scale (VAS). The intensity of pain was evaluated at the baseline (t0), and on the 1st (t1), 2nd (t2), 3rd (t3), 4th (t4), 5th (t5), 6th (t6), and 7th (t7) days following extraction. The Kolmogorov-Smirnov test and the Mann-Whitney U test were performed. The level of significance was set at 0.05 (p < 0.05). RESULTS: The mean vas scores was 4.17 ± 1.76 at t1 and decreased to 0.73 ± 0.78 at t7 in the TXA-Gel group. However, in the Gelfoam group, the mean vas scores was 4.83 ± 2.18 at t1 and decreased to 1.80 ± 1.00 at t7. The results of the Mann-Whitney U test showed that there was no statistically significant difference between the two groups at t1 (p = 0.236) and t2 (p = 0.155). However, there was a statistically significance difference at the rest time points (p < 0.05). CONCLUSIONS: TXA-Gel played a prominent role in alleviating post-extraction pain in warfarin patients. TRIAL REGISTRATION: The trail was retrospectively registered at the ISRCTN registry (ISRCTN71901901).

Effects of tranexamic acid preconditioning on the incidence of postpartum haemorrhage in vaginal deliveries with identified risk factors in China: a prospective, randomized, open-label, blinded endpoint trial.

OBJECTIVE: This study aimed to evaluate the effects of tranexamic acid (TXA) in preventing postpartum haemorrhage (PPH) among women with identified risk factors for PPH undergoing vaginal delivery in China. METHODS: This prospective, randomized, open-label, blinded endpoint (PROBE) trial enrolled 2258 women with one or more risk factors for PPH who underwent vaginal delivery. Participants were randomly assigned in a 1:1 ratio to receive an intravascular infusion of 1 g TXA or a placebo immediately after the delivery of the infant. The primary outcome assessed was the incidence of PPH, defined as blood loss ≥500 mL within 24 h after delivery, while severe PPH was considered as a secondary outcome and defined by total blood loss ≥1000 mL within 24 h. RESULTS: 2245 individuals (99.4%) could be followed up to their primary outcome. PPH occurred in 186 of 1128 women in the TXA group and in 215 of 1117 women in the placebo group (16.5% vs. 19.2%; RR, 0.86; 95% CI, 0.72 to 1.02; p = 0.088). Regarding secondary outcomes related to efficacy, women in the TXA group had a significant lower rate of severe PPH than those in the placebo group (2.7% vs. 5.6%; RR, 0.49; 95% CI, 0.32 to 0.74; p = 0.001; adjusted p = 0.002). Similarly, there was a significant reduction in the use of additional uterotonic agents (7.8% vs. 15.6%; RR, 0.50; 95% CI, 0.39 to 0.63; p < 0.001; adjusted p = 0.001). No occurrence of thromboembolic events and maternal deaths were reported in both groups within 30 days after delivery. CONCLUSIONS: In total population with risk factors for PPH, the administration of TXA following vaginal delivery did not result in a statistically significant reduction in the incidence of PPH compared to placebo; however, it was associated with a significantly lower incidence of severe PPH.

Prophylactic administration of TXA did not yield a statistically significant reduction in the incidence of PPH among women with risk factors in vaginal deliveries.Prophylactic use of TXA may help to reduce the incidence of severe PPH.

Variable Efficacy of Tranexamic Acid in Geriatric Hip Fractures Treated With Arthroplasty Versus Cephalomedullary Nails.

INTRODUCTION: Geriatric hip fractures are associated with high rates of disability and mortality. Many of these patients require perioperative and postoperative allogeneic blood transfusions, which carry several noteworthy risks. A growing body of literature supports the efficacy of tranexamic acid (TXA) in geriatric hip fractures, without sufficient data examining which subgroups are likely to benefit the most. METHODS: In this study, we sought to evaluate whether TXA was associated with reduced blood loss and transfusions in a geriatric population undergoing hip fracture fixation at our institution during a 2-year period. The first year's data were collected in a retrospective fashion before the introduction of a quality control initiative encouraging TXA administration for all geriatric hip fractures. The second year's data were collected prospectively. A subgroup analysis was conducted for patients who underwent arthroplasties. RESULTS: Among the pooled cohort of patients undergoing surgery, TXA showed no benefit over control subjects for reducing blood loss or transfusion requirements. However, the subgroup of patients undergoing arthroplasty procedures showed a notable decrease in total blood loss and total units transfused during hospitalization. DISCUSSION: These results suggest that TXA may be most beneficial when targeted to arthroplasties performed for geriatric hip fractures.

The advantages of using tranexamic acid in anterior cruciate ligament reconstruction: a randomized controlled trial.

OBJECTIVE: The number of participants in sports or some form of recreation globally has led to an increase in the incidence of anterior cruciate ligament (ACL) injuries and the number of surgeries performed. Although it does not belong to risky surgical interventions, this operation is accompanied by complications that slow down post-operative rehabilitation. The objective is to analyze the effects of intra-articular (IA) injection of tranexamic acid (TXA) on the reduction of post-operative drained blood volume, pain intensity, and incidence of hemarthrosis after ACL reconstruction. METHODS: This prospective research included 124 patients undergoing ACL reconstruction surgery, randomly divided into two groups. The TXA group received IA TXA, whereas an equal amount of placebo was administered using the same route in the control group. RESULTS: The research has shown that IA injection of TXA effectively reduces post-operative blood loss (TXA group 71.29 ± 40.76 vs. control group 154.35 ± 81.45), reducing the intensity of post-operative pain (p < 0.001) and the incidence of hemarthrosis. CONCLUSION: The application of TXA significantly reduced post-operative bleeding and pain intensity, which accelerated the post-operative period.

OBJETIVO: El mayor número de participantes en deportes o alguna forma de recreación en todo el mundo ha llevado a un aumento en la incidencia de lesiones del ligamento cruzado anterior (LCA) y de las cirugías realizadas. Aunque no es una intervención quirúrgica de riesgo, esta operación va acompañada de complicaciones que ralentizan la rehabilitación posoperatoria. El objetivo es analizar los efectos de la inyección intraarticular de ácido tranexámico (TXA) sobre la reducción del volumen sanguíneo drenado posoperatorio, la intensidad del dolor y la incidencia de hemartrosis tras la reconstrucción del LCA. MÉTODO: Esta investigación prospectiva incluyó 124 pacientes sometidos a cirugía de reconstrucción del LCA, divididos aleatoriamente en dos grupos: uno recibió TXA intraarticular y otro (grupo de control) una cantidad igual de placebo por la misma vía. RESULTADOS: La investigación ha demostrado que la inyección intraarticular de TXA reduce efectivamente la pérdida de sangre posoperatoria (grupo TXA 71.29 ± 40.76 vs. grupo control 154.35 ± 81.45), reduciendo la intensidad del dolor posoperatorio (p < 0.001) y la incidencia de hemartrosis. CONCLUSIONES: La aplicación de TXA redujo significativamente el sangrado posoperatorio y la intensidad del dolor, lo que aceleró el posoperatorio.

The effect of tranexamic acid on blood transfusion in lower gastrointestinal bleeding-A double blind prospective randomised controlled trial.

PURPOSE: Acute gastrointestinal bleeding is a common emergency. Tranexamic acid (TXA) reduces clot breakdown by inhibiting the action of plasmin and has been shown to reduce the need for blood transfusion in trauma, surgical procedures, and upper gastrointestinal bleeding. This study examined the efficiency of intravenous TXA in patients with acute lower gastrointestinal bleeding. METHODS: Eighty-one patients aged >18 years with lower GI hemorrhage, presenting as active rectal bleeding and anemia (hemoglobin lower than 11 g/dL or a decrease of 2 gr/dl from the patient's base level), were enrolled in this single center, double blind prospective research. Patients were randomly assigned to receive intravenous TXA or placebo from admission until colonoscopy took place. The need for transfusion of packed red blood cells (PRBC) and number of units was recorded and compared between the two groups. RESULTS: Eighty-one patients were randomized in this study, thirty-nine in the TXA arm, and forty-two in the placebo arm. Patient characteristics did not differ between the groups. Forty-three out of the 81 patients received blood transfusion; twenty-two were on the placebo arm and twenty-one on the TXA arm (p = 0.89). Twenty-nine patients required 2 or more units, 14 in the TXA arm and 15 in the placebo arm (p = 0.98). CONCLUSIONS: Intravenous TXA has no significant effect on blood requirement in patients with lower GI bleeding. There was no difference in the consumption of PRBC units among the patients in the placebo and TXA groups. It seems that tranexamic acid has no significant effect on transfusion of PRBC units in lower GI bleeding.

Efficacy and safety of topical application of tranexamic acid in patients undergoing reconstructive plastic surgery after excision of facial skin cancers: a randomised clinical trial.

INTRODUCTION: Tranexamic acid (TA) has attracted increased attention among surgical specialties, but its use in plastic surgery is limited. The aim of this study was to assess the efficacy and safety of topical administration of 3% TA solution in reconstructive surgery of the face and scalp after excision of skin cancers. METHODS: a randomized, double-blind, parallel-group clinical trial was conducted in patients aged 18 years or older with malignant skin neoplasms in the face or scalp region (ICD-10 C44.9). The primary outcome was volume of blood loss in the intraoperative and immediate postoperative period. Secondary outcomes included difficult-to-control intraoperative haemorrhage, hematoma, ecchymosis, and other adverse events. RESULTS: of the 54 included patients, 26 were randomised to TA group and 28 to placebo group. The mean blood loss was 11.42ml (SD 6.40, range 8.83-14.01) in the TA group, and 17.6ml (SD 6.22, range 15.19-20.01) in the placebo group, representing a mean decrease of 6.18ml (35.11%) (p=0.001). TA significantly reduced the risk of ecchymosis (RR = 0.046; 95% CI: 0.007-0.323). Only two patients in the placebo group experienced ischemia in the flaps, and one patient in the placebo group experienced tissue necrosis requiring surgical reintervention. There were no surgical wound infections, thromboembolic phenomena, or other adverse events related to TA. CONCLUSIONS: topical TA may reduce intraoperative and immediate postoperative bleeding, with a significantly decreased risk of ecchymosis. There is no evidence of ischemic damage of flaps, systemic thromboembolic complications, or other adverse events.

The Effect of Intravenous Tranexamic Acid on Perioperative Blood Loss, Transfusion Requirements, Verticalization, and Ambulation in Total Knee Arthroplasty: A Randomized Double-Blind Study.

Background and Objectives: Total knee arthroplasty (TKA) is sometimes associated with significant perioperative bleeding. The aim of this study was to determine the efficacy of tranexamic acid (TXA) in reducing perioperative blood loss in patients undergoing primary TKA. The secondary objectives were to assess the efficacy of TXA in reducing the need for blood transfusion in these patients and to determine its effect on verticalization and ambulation after TKA. Materials and Methods: This study included 96 patients who were randomly assigned to two groups, each containing 48 patients. The study group received intravenous TXA at two time points: immediately after the induction with doses of 15 mg/kg and 10 mg/kg 15 min before the release of the pneumatic tourniquet. The control group received an equivalent volume of 0.9% saline solution via the same route. Results: TXA markedly reduced (Z = -6.512, p < 0.001) the total perioperative blood loss from 892.56 ± 324.46 mL, median 800 mL, interquartile range (IQR) 530 mL in the control group, to 411.96 ± 172.74 mL, median 375 mL, IQR 200 mL, in the TXA group. In the TXA group, only 5 (10.4%) patients received a transfusion, while in the control group, 22 (45.83%) received it (χ2 = 15.536, p = 0.001). Patients in the study group stood (χ2 = 21.162, p < 0.001) and ambulated earlier postoperatively, compared to the control group (χ2 = 26.274, p < 0.001). Patients who received TXA had a better overall postoperative functional recovery. There was a statistically significant difference in all the above results. Conclusions: TXA is an effective drug for reducing the incidence of perioperative bleeding, decreasing transfusion rates, and indirectly improving postoperative functional recovery in patients undergoing primary TKA.

Unraveling Postoperative Bleeding Dynamics in Laparoscopic Roux-en-Y Gastric Bypass: Insights from a Single-Center Tranexamic Acid Study.

BACKGROUND: The efficacy of postoperative tranexamic acid (TXA) administration in mitigating bleeding after primary laparoscopic Roux-en-Y gastric bypass (RYGB), a prevalent complication associated with significant morbidities and mortality, and the use of sequential laboratory parameter changes in bleeding screening and TXA impact tracking were investigated. METHODS: This retrospective analysis included RYGB patients (aged 18-65 years, with a body mass index of 35-50 kg/m2) over 5 years who were categorized into three groups by evolving treatment regimens: Group A (n = 42) received standard pre- and postoperative enoxaparin (30 mg) every 12 h; Group B (n = 160) received enoxaparin and postoperative TXA (250 mg every 6 h); and Group C (n = 73) received TXA alone. Postoperative bleeding-related adverse events, vital signs, and laboratory changes were compared. RESULTS: Postoperative hemorrhage occurred in 3.6% (10/275) of patients, with no significant intergroup differences. Patients who experienced bleeding had greater decreases in hemoglobin (∆Hb) (2.1 vs. 1.4; p = 0.003), greater ∆Hb > 2 (50% vs. 15%; p = 0.013), and greater use of staples than did those who did not experience bleeding (8 vs. 7; p = 0.001). The ∆Hb values were lower in Groups B (1.4) and C (1.3) than in Group A (1.7, p = 0.011). No significant difference was noted between Groups C and B. CONCLUSION: This study emphasizes the potential of TXA to mitigate postoperative bleeding after RYGB, with no added benefit from excluding enoxaparin. Monitoring patients with a ∆Hb > 2 mg/dl and increased stapler usage is crucial. Further research is needed to validate routine TXA use across different procedures.

The efficacy and safety of the internal medication therapy of the triple drugs for chronic subdural hematoma: Retrospective analysis.

The recurrence of chronic subdural hematoma (CSDH) after surgical treatment is a severe problem with no effective prevention method. This retrospective study aimed to investigate factors associated with CSDH recurrence after burr hole surgery and hematoma changes on computed tomography before surgery to examine prevention methods for recurrence. A total of 166 hematomas were enrolled in this study, with 139 patients undergoing burr hole surgery for CSDH. Among these patients, 17 (12 %) had recurrence. Propensity score matching was performed based on postoperative drug therapy, including goreisan, carbazochrome sodium sulfonate hydrate, and tranexamic aid, resulting in 39 matched cases in 0-2 and 3 drug therapy groups. The recurrence rates were 18 % for the 0-2-drug therapy group and 3 % for the 3-drug therapy group. Univariate analysis revealed that the use of 0-2 drugs was associated with a higher risk of CSDH recurrence (odds ratio [OR], 8.31; 95 % confidence interval [CI], 0.97-71.17; p = 0.05) compared to the use of 3 drugs. Multivariate regression analysis further confirmed that 0-2 drug therapy after surgery was associated with an increased risk of CSDH recurrence (OR, 11.06; 95 % CI, 1.16-105.4; p = 0.037). Additionally, 36 hematomas were evaluated before surgery, with hematoma changes such as lower density and new trabecular formation detected in 14 CSDHs (39 %). Multivariate regression analysis showed that 3-drug therapy was associated with more cases of hematoma change than 0-2-drug therapy (OR, 13.9; 95 % CI, 1.09-177.65; p = 0.043). The 3-drug therapy was effective in reducing the recurrence of hematoma after burr hole surgery and promoted hematoma thrombosis.

Antifibrinolytic and Adjunct Hemostatic Agents: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference.

OBJECTIVES: To derive systematic-review informed, modified Delphi consensus regarding antifibrinolytic and adjunct hemostatic agents in neonates and children supported with extracorporeal membrane oxygenation (ECMO) for the Pediatric ECMO Anticoagulation CollaborativE consensus conference. DATA SOURCES: A structured literature search was performed using PubMed, EMBASE, and Cochrane Library (CENTRAL) databases from January 1988 to May 2021. STUDY SELECTION: Use of antifibrinolytics (epsilon-aminocaproic acid [EACA] or tranexamic acid), recombinant factor VII activated (rFVIIa), or topical hemostatic agents (THAs). DATA EXTRACTION: Two authors reviewed all citations independently, with a third independent reviewer resolving conflicts. Eleven references were used for data extraction and informed recommendations. Evidence tables were constructed using a standardized data extraction form. MEASUREMENTS AND MAIN RESULTS: Risk of bias was assessed using the Quality in Prognosis Studies tool. The evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation system. Forty-eight experts met over 2 years to develop evidence-based recommendations and, when evidence was lacking, expert-based consensus statements for the management of bleeding and thrombotic complications in pediatric ECMO patients. A web-based modified Delphi process was used to build consensus via the Research And Development/University of California Appropriateness Method. Consensus was defined as greater than 80% agreement. One weak recommendation and three consensus statements are presented. CONCLUSIONS: Evidence supporting recommendations for administration of antifibrinolytics (EACA or tranexamic acid), rFVIIa, and THAs were sparse and inconclusive. Much work remains to determine effective and safe usage strategies.

Evaluation of the prehospital administration of tranexamic acid for injured patients: a state-wide observational study with sex and age-disaggregated analysis.

BACKGROUND: Tranexamic acid (TXA) decreases mortality in injured patients and should be administered as soon as possible. Despite international guidelines recommending TXA in the prehospital setting, its use remains low. The aim of this study was to assess the prehospital administration of TXA for injured patients in a Swiss region. METHODS: We conducted a retrospective observational study in Switzerland between 2018 and 2021. Inclusion criteria were injured patients ≥18 years for whom an ambulance or helicopter was dispatched. The exclusion criterion was minor injury defined by a National Advisory Committee for Aeronautics score <3. The primary outcome was the proportion of patients treated with TXA according to guidelines. The European guidelines were represented by the risk of death from bleeding (calculated retrospectively using the Bleeding Audit for Trauma and Triage (BATT) score). Factors impacting the likelihood of receiving TXA were assessed by multivariate analysis. RESULTS: Of 13 944 patients included in the study, 2401 (17.2%) were considered at risk of death from bleeding. Among these, 257 (11%) received prehospital TXA. This represented 38% of those meeting US guidelines. For European guidelines, the treatment rate increased with the risk of death from bleeding: 6% (95% CI 4.4% to 7.0%) for low risk (BATT score 3-4); 13% (95% CI 11.1% to 15.9%) for intermediate risk (BATT score 5-7); and 21% (95% CI 17.6% to 25.6%) for high risk (BATT score ≥8) (p<0.01). Women and the elderly were treated less often than men and younger patients, irrespective of the risk of death from bleeding and the mechanism of injury. CONCLUSION: The proportion of injured patients receiving TXA in the prehospital setting of the State of Vaud in Switzerland was low, with even lower rates for women and older patients. The reasons for this undertreatment are probably multifactorial and would require specific studies to clarify and correct them.

Clinical application of tranexamic acid in arthroscopic rotator cuff repair surgery: A randomized controlled trial.

BACKGROUND: To investigate whether intravenous administration of tranexamic acid (TXA) prior to arthroscopic rotator cuff repair improves operative blood loss, postoperative fibrinolytic index, inflammatory response, and postoperative pain. METHODS: This was a prospective, double-blind, randomized controlled study. From January 2023 to February 2024, 64 patients who required arthroscopic rotator cuff repair were included and divided into tranexamic acid group (T group) group and control group (C group) according to the random number table method. In T group, 1000 mg TXA was administered intravenously 10 minutes before surgery, and an equivalent dose of normal saline was administered intravenously 10 minutes before surgery in C group. Intraoperative bleeding, postoperative fibrinolytic indexes, inflammatory indexes, pain scores, and occurrence of adverse effects were compared between the 2 groups. RESULTS: Intraoperative bleeding in T group was lower than that in C group (P < .05); D-D and FDP in T group were significantly lower than those in C group (P < .05); postoperative TNF-α and IL-6 in 2 groups was higher than that before operation and T group was lower than C group (P < .05); The pain scores of the 2 groups after operation were lower than those before operation (P < .05), and there was no difference between the 2 groups (P > .05). CONCLUSION SUBSECTIONS: TXA is able to reduce blood loss and inflammatory reactions, modulate fibrinolytic function, and promote postoperative recovery in patients undergoing arthroscopic rotator cuff repair, with no elevated risk of complications.

Perioperative Administration of Tranexamic Acid and Low Molecular Weight Heparin for Enhanced Blood Management in Intertrochanteric Fractures: A Randomized Controlled Study.

BACKGROUND This prospective study from a single center aimed to compare the perioperative blood loss (PBL) in 79 patients with intertrochanteric fractures (IF) treated with intramedullary nailing (IMN) using 3 regimens of combined tranexamic acid (TXA) and low molecular weight heparin (LMWH), proposing a novel therapy of 4-dose TXA. MATERIAL AND METHODS We recruited 79 patients and randomly divided them into 3 groups. The 4-dose TXA group (22 patients) received 1.0 g intravenous TXA 30 min before surgery and 1.0 g at intervals of 3, 6, and 9 h before surgery. The 1-dose TXA group (25 patients) received 1.0 g intravenous TXA 30 min before surgery, while the control group (32 patients) did not receive TXA. LMWH was applied 12 h after surgery in each group. The primary metrics evaluated included hidden blood loss (HBL), total blood loss (TBL), and the number and incidence rate of deep vein thrombosis (DVT). RESULTS Analysis of the HBL revealed that the 4-dose TXA group had the lowest average (583.13±318.08 ml), followed by the 1-dose TXA group (902.94±509.99 ml), and the control group showed the highest (1154.39±452.06 ml) (P<0.05). A similar result was observed for TBL (4-dose group: 640.86±337.22 ml, 1-dose group: 971.74±511.14 ml, control group: 1226.27±458.22 ml, P<0.05). Regarding DVT, the 4-dose TXA group had 5 cases (incidence rate 22.73%), the 1-dose TXA group had 6 cases (incidence rate 24.00%), and the control group had 8 cases (incidence rate 25.00%), with no significant difference among groups (P>0.05). CONCLUSIONS Treatment using 4-dose TXA and LMWH can effectively reduce PBL without increasing the DVT risk in IF patients with IMN.