- Research Article
11
- 10.4037/aacnacc2021193
New and Off-Label Uses of Tranexamic Acid.
- Sep 15, 2021
- AACN Advanced Critical Care
- Stephanie M Johnson + 3 more +3
New and Off-Label Uses of Tranexamic Acid.
Perioperative bleeding is a significant concern in hepatic surgeries, leading to increased morbidity, blood transfusions, and associated risks. Tranexamic acid (TXA) is effective in reducing blood loss in various surgical procedures, but its efficacy in liver surgeries remains uncertain. PubMed, CENTRAL, Web of Science, Embase, and Scopus were systematically searched without any automated filters through 20th October 2024. Continuous data were reported in mean difference (MD) with 95% confidence interval (95% CI), and dichotomous data were reported in odds ratio (OR) with 95% CI. STATA Corp M17 was used to analyze our outcomes. Six RCTs were analyzed, including 1,618 patients undergoing liver surgeries (resections or transplants). TXA did not significantly reduce the need for postoperative blood transfusion (OR 0.72; 95% CI [0.35-1.47], p = 0.37; I2 = 52.9%). TXA also showed no significant effect on intraoperative RBC units (MD - 1.31; 95% CI [-3.41 to 0.78], p = 0.22; I2 = 72.14%). No increased risk of thrombotic events (OR 1.68; 95% CI [0.98-2.88], p = 0.06; I2 = 0%) or mortality (OR 1.05; 95% CI [0.57-1.91], p = 0.88; I2 = 0%) was observed. TXA did not significantly reduce blood loss or hospital stay duration. TXA demonstrates no significant benefit in reducing perioperative bleeding or transfusion requirements in hepatic surgeries. It might be safe, with no increased thrombotic risk, but its clinical utility in this surgical context remains questionable. Further large-scale RCTs are needed to clarify its role in liver surgeries.
New and Off-Label Uses of Tranexamic Acid.
New and Off-Label Uses of Tranexamic Acid.
Tranexamic acid for patients with nasal haemorrhage (epistaxis).
We found moderate-quality evidence that there is probably a reduction in the risk of re-bleeding with the use of either oral or topical tranexamic acid in addition to usual care in adult patients with epistaxis, compared to placebo with usual care. However, the quality of evidence relating solely to topical tranexamic acid was low (one study only), so we are uncertain whether or not topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application. We found moderate-quality evidence that topical tranexamic acid is probably better than other topical agents in stopping bleeding in the first 10 minutes.There have been only three RCTs on this subject since 1995. Since then there have been significant changes in nasal cauterisation and packing techniques (for example, techniques including nasal endoscopy and more invasive approaches such as endoscopic sphenopalatine artery ligation). New trials would inform us about the effectiveness of tranexamic acid in light of these developments.
Read moreTranexamic acid for significant traumatic brain injury (The CRASH-3 trial): Statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial.
Background: Worldwide, traumatic brain injury (TBI) kills or hospitalises over 10 million people each year. Early intracranial bleeding is common after TBI, increasing the risk of death and disability. Tranexamic acid reduces blood loss in surgery and death due to bleeding in trauma patients with extra-cranial injury. Early administration of tranexamic acid in TBI patients might limit intracranial bleeding, reducing death and disability. The CRASH-3 trial aims to provide reliable evidence on the effect of tranexamic acid on death and disability in TBI patients. We will randomly allocate about 13,000 TBI patients to an intravenous infusion of tranexamic acid or matching placebo in addition to usual care. This paper presents a protocol update (version 2.1) and statistical analysis plan for the CRASH-3 trial. Results: The primary outcome is head injury death in hospital within 28 days of injury for patients treated within 3 hours of injury (deaths in patients treated after 3 hours will also be reported). Because there are strong scientific reasons to expect that tranexamic acid will be most effective in patients treated immediately after injury and less effective with increasing delay, the effect in patients treated within one hour of injury is of particular interest. Secondary outcomes are all-cause and cause-specific mortality, vascular occlusive events (myocardial infarction, pulmonary embolism, deep vein thrombosis, stroke), disability based on the Disability Rating Scale and measures suggested by patient representatives, seizures, neurosurgical intervention, neurosurgical blood loss, days in intensive care and adverse events. Sub-group analyses will examine the effect of tranexamic acid on head injury death stratified by time to treatment, severity of TBI and baseline risk. Conclusion: The CRASH-3 trial will provide reliable evidence of the effectiveness and safety of tranexamic acid in patients with acute TBI. Registration: International Standard Randomised Controlled Trials registry ( ISRCTN15088122) 19/07/2011, and ClinicalTrials.gov ( NCT01402882) 25/07/2011.
Read moreP119. Does the use of IV tranexamic acid impact postoperative hemoglobin and hematocrit following anterior cervical discectomy and fusion?
P119. Does the use of IV tranexamic acid impact postoperative hemoglobin and hematocrit following anterior cervical discectomy and fusion?
Read moreEffectiveness of tranexamic acid in reducing blood loss in spinal surgery: a meta-analysis
BackgroundThe aim of present meta-analysis was to evaluate the effectiveness of tranexamic acid (TXA) use in reducing blood loss and the related thrombotic complications in spinal surgery.MethodsThree databases (MEDLINE, EMBASE, and the Cochrane Library) were searched through October 2012 to identify the relevant randomized controlled trials (RCTs) regarding the TXA effective in spinal surgery. Mean differences (MDs) of blood loss, blood transfusions, and postoperative partial thromboplastic time (PTT), odds ratios (ORs) of blood transfusion and thrombotic complication in TXA-treated group compared to placebo group were extracted and combined using random-effect meta-analysis.ResultsA total of 6 RCTs comprising 411 patients were included in the meta-analysis according to the pre-defined selection criteria. TXA-treated group had significantly less amount of blood loss and blood transfusions per patient, and had smaller proportion of patients who required a blood transfusion compared with the placebo group. The use of TXA can significantly reduce the postoperative PTT with weighted MD of -1.59 [(95% confidence interval (CI):-3.07, -0.10] There is a null association between thrombosis complications and the use of TXA.ConclusionWe conclude that the use of TXA in patients undergoing spinal surgery appears to be effective in reducing the amount of blood loss, the volume of blood transfusion, the transfusion rate, and the postoperative PTT. However, data were too limited for any conclusions regarding safety. More high-quality RCTs are required before recommending the administered of TXA in spinal surgery.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2474-15-448) contains supplementary material, which is available to authorized users.
Read moreVliv tranexamové kyseliny na perioperační krevní ztrátu a rozvoj hematomu v ráně u operací bederní páteře: prospektivní randomizovaná studie
PURPOSE OF THE STUDY Tranexamic acid as a haemostatic agent is commonly used in multiple medical branches. Over the last decade, there has been a steep rise in the number of studies evaluating its effect, i.e. blood loss reduction in specific surgical procedures. The aim of our study was to evaluate the effect of tranexamic acid on reducing intraoperative blood loss, postoperative blood loss into the drain, total blood loss, transfusion requirements, and development of symptomatic wound hematoma in conventional single-level lumbar decompression and stabilization. MATERIAL AND METHODS The study included patients who had undergone a traditional open lumbar spine surgery in the form of single-level decompression and stabilisation. The patients were randomized into two groups. The study group received a 15 mg/kg dose of tranexamic acid intravenously during the induction of anaesthesia and then again 6 hours later. No tranexamic acid was administered to the control group. In all patients, intraoperative blood loss, postoperative blood loss into the drain, and therefore also total blood loss, transfusion requirements and potential development of a symptomatic postoperative wound hematoma requiring surgical evacuation were recorded. The data of the two groups were compared. RESULTS The cohort includes 162 patients, 81 in the study group and the same number in the control group. In the intraoperative blood loss assessment, no statistically significant difference between the two groups was observed; 430 (190-910) mL vs. 435 (200-900) mL. In case of post-operative drain blood loss, a statistically significantly lower volume was reported after the tranexamic acid administration; 405 (180-750) mL vs. 490 (210-820) mL. When evaluating the total blood loss, a statistically significant difference was also confirmed, namely in favour of the tranexamic acid; 860 (470-1410) mL vs. 910 (500- 1420) mL. The reduction of total blood loss did not result in a difference in the number of administered transfusions; transfusions were given to 4 patients in each group. A postoperative wound hematoma requiring surgical evacuation developed in 1 patient in the group with the tranexamic acid and in 4 patients in the control group, but the difference was not statistically significant with respect to the insufficient group size. No patient in our study experienced complications associated with tranexamic acid application. DISCUSSION The beneficial effect of tranexamic acid on reducing blood loss in lumbar spine surgeries has already been confirmed by numerous meta-analyses. The question remains in what types of procedures, at what dose and route of administration its effect is significant. To date, most of the studies have explored its effect in multi-level decompressions and stabilizations. Raksakietisak et al., for instance, report significant reduction in total blood loss from 900 (160, 4150) mL to 600 (200, 4750) mL following an intravenous injection of 2 bolus doses of 15 mg/kg tranexamic acid. In less extensive spinal surgeries, the effect of tranexamic acid may not be that distinct. In our study of single-level decompressions and stabilizations, no reduction in the actual intraoperative bleeding was confirmed at the given dosage. Its effect was seen only in the postoperative period in a significant reduction of blood loss into the drain, thus also in the total blood loss, although the difference between 910 (500, 1420) mL and 860 (470, 1410) mL was not that significant. CONCLUSIONS By intravenous application of tranexamic acid in 2 bolus doses in single-level decompression and stabilization of the lumbar spine a statistically significant reduction in postoperative blood loss into the drain and also total blood loss was confirmed. The reduction in the actual intraoperative blood loss was not statistically significant. No difference was observed in the number of administered transfusions. Following the tranexamic acid administration, a lower number of postoperative symptomatic wound hematomas was recorded, but the difference was not statistically significant. Key words: tranexamic acid, spinal surgeries, blood loss, postoperative hematoma.
Read moreEffect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial
The benefit of tranexamic acid (TXA) in pediatric cardiac surgery on postoperative bleeding has varied among studies. It is also unclear whether the effects of TXA differ between cyanotic patients and acyanotic patients. The aim of this study was to test the benefit of TXA in pediatric cardiac surgery in a well-balanced study population of cyanotic and acyanotic patients. A total of 160 pediatric patients undergoing cardiac surgery with cardiopulmonary bypass (81 cyanotic, 79 acyanotic) were included in this single-blinded, randomized trial at a tertiary care university-affiliated teaching hospital. Eighty-one children (41 cyanotic, 40 acyanotic) were randomly assigned to a TXA group, in which they received 50 mg/kg of TXA as a bolus followed by 15 mg/kg/h infusion and another 50 mg/kg into the bypass circuit. The other 79 patients were randomly assigned to a placebo group. The primary end point was the amount of 24-h blood loss. The amount of 24-h blood loss was significantly less in the TXA group than in the placebo group [mean (95% confidence interval): 18.6 (15.8-21.4) vs. 23.5 (19.4-27.5) ml/kg, respectively; mean difference -4.9 (-9.7 to -0.01) ml/kg; p = 0.049]. This effect of TXA was already significant at 6 h [9.5 (7.5-11.5) vs. 13.2 (10.6-15.9) ml/kg, respectively; mean difference -3.47 (-7.0 to -0.4) ml/kg; p = 0.027]. However, there was no significant difference in the amount of blood transfusion between the groups. There was also no statistical difference in the effect of TXA in each cyanotic and acyanotic subgroup. TXA can reduce blood loss in pediatric cardiac surgery but not the transfusion requirement (http://ClinicalTrials.gov number NCT00994994).
Read moreEffect of tranexamic acid in traumatic brain injury: a nested randomised, placebo controlled trial (CRASH-2 Intracranial Bleeding Study)
Objective To assess the effect of tranexamic acid (which reduces bleeding in surgical patients and reduces mortality due to bleeding in trauma patients) on intracranial haemorrhage in patients with traumatic...
Read morePeri-articular administration of tranexamic acid is an alternative route in total knee arthroplasty: a systematic review and meta-analysis
BackgroundAs an antifibrinolytic agent, tranexamic acid (TXA) is increasingly used in total knee arthroplasty (TKA) to reduce blood loss. The administration of intravenous and intra-articular TXA has been well explored, but the most efficient way to administer TXA remains in question. Peri-articular injection (PAI) of TXA is a recently mentioned method. A meta-analysis of the efficacy of PAI TXA in patients after TKA should be performed.MethodsA systematic search was performed within PubMed, Embase, and the Cochrane Library up to November 8, 2021. Two authors independently screened studies for eligibility and extracted data for analysis. The primary outcome was haemoglobin change. The secondary outcomes were haematocrit change, total drainage volume, thromboembolic events, and blood transfusion.ResultsA total of ten studies were included in this meta-analysis. The results indicated that there was a significant decrease in haemoglobin change when using PAI TXA compared with no TXA (mean difference − 1.05; 95% CI − 1.28 to − 0.81; P < 0.00001; I2 = 0%), but it had no significant differences compared with IA and IV (mean difference − 0.01; 95% CI − 0.17 to − 0.14; P = 0.85; I2 = 39%). There were no significant differences between the TXA < 1.5 g subgroup (0.10, 95% CI − 0.27 to 0.46; P = 0.60; I2 = 0%) and the TXA ≥ 1.5 g subgroup (0.18, 95% CI − 0.12 to 0.48; P = 0.24; I2 = 74%). In addition, the combined group (PAI plus IV or IA) was superior to the IV or IA group in terms of haemoglobin change (mean difference − 0.51; 95% CI − 0.76 to − 0.27; P < 0.0001; I2 = 19%). Regarding haematocrit change, the pooled result showed it was significantly less in the PAI group than the non-TXA group. Similarly, comparing it against the IV subgroup, the result revealed a difference in favour of the PAI group, with a mean difference of − 1.89 g/dL (95% CI − 2.82 to − 0.95; P < 0.0001; I2 = 67%). For total drainage volume, the pooled result was in favour of PAI TXA over no TXA (297 ml, 95% CI − 497.26 to − 97.23; P = 0.004; I2 = 87%), but it had no significant difference compared with IA and IV (mean difference − 37.98; 95% CI − 115.68 to 39.71; P = 0.34; I2 = 95%). There was no significant difference in thromboembolic events (OR 0.74; 95% CI 0.25 to 2.21; P = 0.59; I2 = 0%). Blood transfusion was not significantly different between the PAI group and the non-TXA group (OR 0.50; 95% CI 0.23 to 1.06; P = 0.07; I2 = 21%), and there was no significant difference between PAI and the other two TXA injection methods (OR 0.72; 95% CI 0.41 to 1.25; P = 0.24; I2 = 19%).ConclusionPAI has comparable effects to IV and IA injections. PAI is an alternative injection route of TXA for patients who have undergone TKA.
Read moreRole of prophylactic use of tranexamic acid in reducing blood loss during caesarean section in a tertiary care hospital
Postpartum Haemorrhage (PPH) is an important cause of maternal death and severe maternal morbidity. Compared to vaginal delivery, women undergoing caesarean delivery incur the highest risk of PPH and haemorrhage related morbidity. Furthermore, evidence suggests that PPH during caesarean delivery is occurring more frequently. To study the effect of low dose intravenous tranexamic acid in reducing blood loss during Caesarean section.: This randomized control trial among 50 antenatal women aged &#62;18 years undergoing Lower segment caesarean section in tertiary care centre. They were divided into Study group and control group. Study group received 1gm iv tranexamic acid and the Control group did not receive tranexamic acid. Data was entered in Microsoft Excel data sheet (MS-Excel) and analysed using commercially available SPSS 23 software package. MS Excel and MS word was used to obtain various types of graphs such as bar diagram. : Among the study population who underwent Lower section caesarean section in our study, we found that the requirement of additional oxytocin was nil with tranexamic acid group (p value&#60;0.02). There were no side effects observed with the group administered tranexamic acid (p value&#60;0.01). The difference in mean of bleeding from placental delivery to end of Caesarean Section, End of Caesarean Section to 2 hrs Postpartum was statistically significant (p value &#60;0.05). The fall in Hb% between the two groups was significant, thereby showing the benefits of Tranexamic acid.: Tranexamic acid significantly reduces the amount of blood loss during and after lower segment caesarean section. It was not associated with any significant side effects and complications. It can be used effectively in all women undergoing caesarean section to reduce the postpartum Haemorrhage thereby reducing the maternal morbidity and mortality.
Read moreEfficacy of Tranexamic Acid in Pediatric Craniosynostosis Surgery
Extensive blood loss is common in pediatric craniosynostosis reconstruction surgery. Tranexamic acid (TXA) is increasingly used to reduce perioperative blood loss in various settings, but data on its efficacy are limited in children. The purpose of this randomized, double-blind, placebo-controlled, parallel trial was to evaluate the efficacy of TXA in pediatric craniosynostosis correction surgery. The primary and secondary outcome variables were reduction in perioperative blood loss and reduction in blood transfusion, respectively. Forty-three children, ages 2 months to 6 yr, received either placebo or TXA in a loading dose of 50 mg·kg(-1), followed by an infusion of 5 mg·kg·h(-1) during surgery. TXA plasma concentrations were measured. The TXA group had significantly lower perioperative mean blood loss (65 vs. 119 ml·kg(-1), P < 0.001) and lower perioperative mean blood transfusion (33 vs. 56 ml· kg(-1), P = 0.006) compared to the placebo group. The mean difference between the TXA and placebo groups for total blood loss was 54 ml·kg(-1) (95% CI for the difference, 23-84 ml·kg(-1)) and for packed erythrocytes transfused was 23 ml·kg(-1) (95% CI for the difference, 7-39 ml·kg(-1)). TXA administration also significantly diminished (by two thirds) the perioperative exposure of patients to transfused blood (median, 1 unit vs. 3 units; P < 0.001). TXA plasma concentrations were maintained above the in vitro thresholds reported for inhibition of fibrinolysis (10 μg·ml(-1)) and plasmin-induced platelet activation (16 μg·ml(-1)) throughout the infusion. TXA is effective in reducing perioperative blood loss and transfusion requirement in children undergoing craniosynostosis reconstruction surgery.
Read moreTranexamic acid and blood loss during and after cesarean section: a meta-analysis.
A meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate whether tranexamic acid (TXA) could significantly reduce blood loss during and after cesarean section (CS) when compared with no TXA. MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials and Web of Science were searched to identify RCTs that compared intravenous TXA with no TXA before CS for blood loss. The related data were extracted by two independent authors. The fixed or random-effect methods were used to combine data. Eleven RCTs were included in this analysis with a total of 1276 women in TXA group and 1255 in no TXA (control) group. Total blood loss during and after CS was significantly less in TXA group than in control group (mean difference (MD) -141.61 ml, 95% confidence interval (CI) -207.09 to -76.14, P<0.01). There was a significant reduction in intraoperative and postpartum blood loss in TXA group as compared with control group (MD -143.36 ml, 95% CI -220.38 to -66.35, P<0.01; and MD -38.20 ml, 95% CI -59.27 to -17.12, P<0.01, respectively). Declines in hemoglobin and hematocrit values after CS were both significantly less in TXA group than in control group. The difference of postpartum hemorrhage rate was statistically significant between groups (risk ratio (RR) 0.57, 95% CI 0.37 to 0.89, P=0.01). The need for blood transfusion was significantly less in TXA group than control group (RR 0.23, 95% CI 0.10 to 0.57, P<0.01). Our results demonstrate that TXA offers an advantage over no TXA in reducing blood loss during and after CS.
Read moreIs topical or intravenous tranexamic acid preferred in total hip arthroplasty? A randomized, controlled, noninferiority clinical trial
PurposeThe present study aimed to confirm the efficacy and safety of topical and intravenous tranexamic acid (TXA) compared with that of topical placebo and to assess the noninferiority between the two application methods of TXA in patients undergoing unilateral primary total hip arthroplasty.MethodsOur randomized controlled trial investigated 170 patients with 1:1:1 allocation to two doses of 10-mg/kg intravenous TXA, 3-g topical TXA, and topical placebo of 60-ml physiological saline groups. The primary outcome, total blood loss, was calculated with Nadler and Gross formula. The secondary outcomes included allogeneic blood transfusion requirement, drain blood loss, decreased hemoglobin level. Noninferiority would be established when the upper limit 95% CI is lower than 250 ml of the noninferiority margin for the mean difference of total blood loss between topical and intravenous TXA. Thromboembolic complication incidence was considered as a safety outcome.ResultsThe total blood loss of patients administered intravenous (mean±standard deviation, 1125±514 ml) and topical TXA (1211±425 ml) was significantly reduced compared with that of those administered topical placebo (1464±556 ml) (p = 0.0012). Drain blood loss and hemoglobin level reduction in patients administered with TXA were also significantly lower than those in patients administered topical placebo. The mean difference of total blood loss between topical and intravenous TXA is 86 ml (95% CI, −88 to 260 ml). The complications were comparable between patients managed with TXA and patients with topical placebo.ConclusionThe noninferiority of topical TXA to intravenous TXA can not be concluded. Considering no significant difference was found in all efficacy outcomes between the two administration methods. Any of the two TXA administration methods can be adopted for blood loss prevention in total hip arthroplasty.
Read moreThe impact of tranexamic acid on mortality in injured patients with hyperfibrinolysis
In 2011, supported by data from two separate trauma centers, we implemented a protocol to administer tranexamic acid (TXA) in trauma patients with evidence of hyperfibrinolysis (HF) on admission. The purpose of this study was to examine whether the use of TXA in patients with HF determined by admission rapid thrombelastography was associated with improved survival. Following institutional review board approval, we evaluated all trauma patients 16 years or older admitted between September 2009 and September 2013. HF was defined as LY-30 of 3% or greater. Patients with LY-30 less than 3.0% were excluded. Patients were divided into those who received TXA (TXA group) and those who did not (no-TXA group). After univariate analyses, a purposeful, logistic regression model was developed a priori to evaluate the impact of TXA on mortality (controlling for age, sex, Injury Severity Score (ISS), arrival physiology, and base deficit). A total of 1,032 patients met study criteria. Ninety-eight (10%) received TXA, and 934 (90%) did not. TXA patients were older (median age, 37 years vs. 32 years), were more severely injured (median ISS, 29 vs. 14), had a lower blood pressure (median systolic blood pressure 103 mm Hg vs. 125 mm Hg), and were more likely to be in shock (median, base excess, -5 mmol/dL vs. -2 mmol/dL), all p < 0.05. Twenty-three percent of the patients had a repeat thrombelastography within 6 hours; 8.8% of the TXA patients had LY-30 of 3% or greater on repeat rapid thrombelastography (vs. 10.1% in the no-TXA group, p = 0.679). Unadjusted in-hospital mortality was higher in the TXA group (40% vs. 17%, p < 0.001). There were no differences in venous thromboembolism (3.3% vs. 3.8%). Logistic regression failed to find a difference in in-hospital mortality among those receiving TXA (odds ratio, 0.74; 95% confidence interval, 0.38-1.40; p 0.80). In the current study, the use of TXA was not associated with a reduction in mortality. Further studies are needed to better define who will benefit from an administration of TXA. Therapeutic study, level IV.
Read moreEffect of oxytocin infusion versus tranexamic acid on reducing blood loss during hysteroscopic myomectomy: a randomized controlled trial
Background: Women undergoing hysteroscopic myomectomy are prone to significant blood loss and hematological disturbances. Oxytocin is a uterotonic drug, used mainly in obstetric practice. Tranexamic acid is a haemostatic drug that has been used to reduce blood loss after trauma and in many surgeries. The aim of our study was to compare the safety and efficacy of oxytocin versus tranexamic acid in reducing perioperative blood loss during hysteroscopic myomectomy.Methods: This study included 60 patients scheduled for hysteroscopic myomectomy allocated into 2 groups: group A: received 10 mg/kg of tranexamic acid slowly intravenous after induction of anesthesia, while group B: received infusion of 10 IU of oxytocin at a rate of 400 mIU/min throughout the procedure. Preoperative and postoperative hemoglobin and hematocrit levels, need for blood transfusion, duration of operation, complications and medications adverse effects were recorded.Results: The 2 groups were comparable in terms of the mean difference between preoperative and postoperative hemoglobin a hematocrit levels, operative time, operative complication and medications’ adverse effects. No patients needed blood component transfusion in either group.Conclusions: It can be concluded that tranexamic acid and oxytocin are equally effective in reducing blood loss and transfusion requirements during hysteroscopic myomectomy with comparable good safety profiles. Both of them can be used according to availability and surgeon preferences.
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